Trial Outcomes & Findings for Treatment of Partial-Thickness Rotator Cuff Tears (NCT NCT03734536)
NCT ID: NCT03734536
Last Updated: 2024-11-19
Results Overview
American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
168 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2024-11-19
Participant Flow
First participant consented 05 December 2018; study premature termination 14 February 2023 with last participant termination on 11 September 2023.
There were 168 participants enrolled in the study with 50 participants excluded during surgery or prior to surgery that resulted in 118 participants being treated and allocated into treatment arms.
Participant milestones
| Measure |
REGENETEN™ Bioinductive Implant
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
REGENETEN™ Bioinductive Implant
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
Baseline Characteristics
Treatment of Partial-Thickness Rotator Cuff Tears
Baseline characteristics by cohort
| Measure |
REGENETEN™ Bioinductive Implant
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.51 years
STANDARD_DEVIATION 10.57 • n=99 Participants
|
58.98 years
STANDARD_DEVIATION 8.14 • n=107 Participants
|
55.75 years
STANDARD_DEVIATION 9.94 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · White
|
55 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Black or African American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · African/Caribbean
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=99 Participants
|
59 participants
n=107 Participants
|
118 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
31.08 kg/m^2
STANDARD_DEVIATION 8.30 • n=99 Participants
|
29.41 kg/m^2
STANDARD_DEVIATION 4.81 • n=107 Participants
|
30.25 kg/m^2
STANDARD_DEVIATION 6.80 • n=206 Participants
|
|
Index shoulder
Left
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Index shoulder
Right
|
40 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Index shoulder
Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain
No
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain
Yes
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain
Missing
|
53 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Surgery on Dominant Arm
Yes
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Surgery on Dominant Arm
No
|
12 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Surgery on Dominant Arm
Missing
|
25 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication
No
|
44 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication
Yes
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication
No
|
56 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication
Yes
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Steroid Injection(s)
No
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Steroid Injection(s)
Yes
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Steroid Injection(s)
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Shoulder Surgery
No
|
55 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Shoulder Surgery
Yes
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Treatment to Manage Index Shoulder: Shoulder Surgery
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Overall number of participants with available data for each treatment at the time frame indicated
American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=56 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=58 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Score
Baseline
|
52.10 score on a scale
Standard Deviation 15.61
|
59.46 score on a scale
Standard Deviation 17.07
|
|
American Shoulder and Elbow Surgeons (ASES) Score
3 months
|
74.61 score on a scale
Standard Deviation 12.35
|
80.07 score on a scale
Standard Deviation 13.30
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12Population: Overall number of participants with available data for the treatment and time frame indicated.
American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=56 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=58 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 10
|
69.62 score on a scale
Standard Deviation 11.69
|
76.81 score on a scale
Standard Deviation 11.43
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 9
|
66.05 score on a scale
Standard Deviation 12.54
|
73.70 score on a scale
Standard Deviation 13.94
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 11
|
71.80 score on a scale
Standard Deviation 13.43
|
78.14 score on a scale
Standard Deviation 11.94
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 12
|
74.61 score on a scale
Standard Deviation 12.35
|
80.07 score on a scale
Standard Deviation 13.30
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Baseline
|
52.10 score on a scale
Standard Deviation 15.61
|
59.46 score on a scale
Standard Deviation 17.07
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 1
|
44.42 score on a scale
Standard Deviation 11.22
|
49.00 score on a scale
Standard Deviation 13.42
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 2
|
50.04 score on a scale
Standard Deviation 12.92
|
54.77 score on a scale
Standard Deviation 13.04
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 3
|
51.77 score on a scale
Standard Deviation 12.62
|
57.67 score on a scale
Standard Deviation 13.65
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 4
|
51.77 score on a scale
Standard Deviation 11.19
|
60.22 score on a scale
Standard Deviation 12.69
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 5
|
56.89 score on a scale
Standard Deviation 9.84
|
63.90 score on a scale
Standard Deviation 12.91
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 6
|
59.06 score on a scale
Standard Deviation 11.77
|
66.25 score on a scale
Standard Deviation 13.05
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 7
|
62.18 score on a scale
Standard Deviation 12.66
|
66.72 score on a scale
Standard Deviation 14.42
|
|
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
Week 8
|
63.74 score on a scale
Standard Deviation 11.98
|
70.74 score on a scale
Standard Deviation 13.98
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12Population: Overall number of participants with available data for the treatment and time frame indicated.
Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Baseline
|
36.78 score on a scale
Standard Deviation 17.90
|
47.42 score on a scale
Standard Deviation 21.34
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 1
|
17.85 score on a scale
Standard Deviation 17.23
|
28.22 score on a scale
Standard Deviation 21.63
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 2
|
24.27 score on a scale
Standard Deviation 17.86
|
35.37 score on a scale
Standard Deviation 20.93
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 3
|
31.94 score on a scale
Standard Deviation 16.35
|
39.89 score on a scale
Standard Deviation 18.79
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 4
|
42.27 score on a scale
Standard Deviation 17.18
|
45.73 score on a scale
Standard Deviation 16.76
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 5
|
40.19 score on a scale
Standard Deviation 18.56
|
49.00 score on a scale
Standard Deviation 17.18
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 6
|
42.27 score on a scale
Standard Deviation 17.18
|
54.60 score on a scale
Standard Deviation 16.83
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 7
|
46.56 score on a scale
Standard Deviation 16.48
|
56.35 score on a scale
Standard Deviation 18.59
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 8
|
49.77 score on a scale
Standard Deviation 15.81
|
59.91 score on a scale
Standard Deviation 19.88
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 9
|
53.55 score on a scale
Standard Deviation 15.17
|
61.82 score on a scale
Standard Deviation 18.22
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 10
|
57.27 score on a scale
Standard Deviation 15.15
|
67.66 score on a scale
Standard Deviation 16.23
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 11
|
59.45 score on a scale
Standard Deviation 18.04
|
69.86 score on a scale
Standard Deviation 14.80
|
|
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
Week 12
|
63.89 score on a scale
Standard Deviation 16.11
|
73.31 score on a scale
Standard Deviation 16.38
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12Population: Overall number of participants with available data for the treatment and time frame indicated.
Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=56 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=58 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Baseline
|
5.49 score on a scale
Standard Deviation 2.49
|
4.35 score on a scale
Standard Deviation 2.54
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 1
|
4.15 score on a scale
Standard Deviation 2.23
|
3.53 score on a scale
Standard Deviation 2.27
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 2
|
3.49 score on a scale
Standard Deviation 2.02
|
3.03 score on a scale
Standard Deviation 2.14
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 3
|
3.29 score on a scale
Standard Deviation 2.25
|
2.65 score on a scale
Standard Deviation 2.10
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 4
|
3.34 score on a scale
Standard Deviation 1.98
|
2.42 score on a scale
Standard Deviation 2.09
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 5
|
2.84 score on a scale
Standard Deviation 1.64
|
2.32 score on a scale
Standard Deviation 1.99
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 6
|
2.77 score on a scale
Standard Deviation 1.90
|
2.15 score on a scale
Standard Deviation 1.94
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 7
|
2.58 score on a scale
Standard Deviation 1.90
|
2.20 score on a scale
Standard Deviation 2.13
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 8
|
2.41 score on a scale
Standard Deviation 1.66
|
1.79 score on a scale
Standard Deviation 2.01
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 9
|
2.41 score on a scale
Standard Deviation 1.73
|
1.57 score on a scale
Standard Deviation 1.91
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 10
|
1.97 score on a scale
Standard Deviation 1.58
|
1.32 score on a scale
Standard Deviation 1.55
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 11
|
1.92 score on a scale
Standard Deviation 2.00
|
1.27 score on a scale
Standard Deviation 1.62
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
Week 12
|
1.79 score on a scale
Standard Deviation 1.75
|
1.31 score on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months and 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=56 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=55 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
12 months
|
91.98 score on a scale
Standard Deviation 12.90
|
90.83 score on a scale
Standard Deviation 16.55
|
|
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
Baseline
|
52.10 score on a scale
Standard Deviation 15.61
|
59.46 score on a scale
Standard Deviation 17.07
|
|
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
6 months
|
87.42 score on a scale
Standard Deviation 11.25
|
90.38 score on a scale
Standard Deviation 11.73
|
|
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
18 months
|
92.87 score on a scale
Standard Deviation 13.40
|
94.71 score on a scale
Standard Deviation 13.07
|
|
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
24 months
|
94.17 score on a scale
Standard Deviation 11.76
|
94.77 score on a scale
Standard Deviation 13.76
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months and 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
12 months
|
87.86 score on a scale
Standard Deviation 14.64
|
87.27 score on a scale
Standard Deviation 17.35
|
|
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
18 months
|
90.03 score on a scale
Standard Deviation 10.30
|
91.74 score on a scale
Standard Deviation 12.52
|
|
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
24 months
|
94.20 score on a scale
Standard Deviation 8.07
|
90.67 score on a scale
Standard Deviation 19.17
|
|
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
Baseline
|
36.78 score on a scale
Standard Deviation 17.90
|
47.42 score on a scale
Standard Deviation 21.34
|
|
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
6 months
|
81.15 score on a scale
Standard Deviation 14.12
|
86.18 score on a scale
Standard Deviation 12.47
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months and 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=56 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=55 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
Baseline
|
5.49 score on a scale
Standard Deviation 2.49
|
4.35 score on a scale
Standard Deviation 2.54
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
6 months
|
0.89 score on a scale
Standard Deviation 1.38
|
0.79 score on a scale
Standard Deviation 1.56
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
12 months
|
0.68 score on a scale
Standard Deviation 1.62
|
1.09 score on a scale
Standard Deviation 2.12
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
18 months
|
0.77 score on a scale
Standard Deviation 1.75
|
0.50 score on a scale
Standard Deviation 1.56
|
|
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
24 months
|
0.47 score on a scale
Standard Deviation 1.15
|
0.48 score on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, and 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function \& lower scores indicating worse shoulder function.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=50 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=48 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
Baseline
|
45.40 score on a scale
Standard Deviation 14.13
|
53.73 score on a scale
Standard Deviation 15.81
|
|
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
3 months
|
52.35 score on a scale
Standard Deviation 12.08
|
60.73 score on a scale
Standard Deviation 12.05
|
|
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
6 months
|
61.13 score on a scale
Standard Deviation 11.62
|
66.10 score on a scale
Standard Deviation 10.57
|
|
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
12 months
|
66.24 score on a scale
Standard Deviation 12.45
|
69.33 score on a scale
Standard Deviation 11.11
|
|
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
24 months
|
71.18 score on a scale
Standard Deviation 9.08
|
71.76 score on a scale
Standard Deviation 8.65
|
SECONDARY outcome
Timeframe: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12Population: Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=27 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=22 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Directly after surgery
|
3.10 defined daily dose
Standard Deviation 7.53
|
7.82 defined daily dose
Standard Deviation 22.93
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 1
|
4.22 defined daily dose
Standard Deviation 10.93
|
18.28 defined daily dose
Standard Deviation 42.90
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 2
|
1.73 defined daily dose
Standard Deviation 2.05
|
4.38 defined daily dose
Standard Deviation 6.12
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 3
|
3.35 defined daily dose
Standard Deviation 5.12
|
3.85 defined daily dose
Standard Deviation 3.21
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 4
|
2.58 defined daily dose
Standard Deviation 2.20
|
2.81 defined daily dose
Standard Deviation 1.64
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 5
|
1.97 defined daily dose
Standard Deviation 2.01
|
1.17 defined daily dose
Standard Deviation 0.85
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 6
|
1.98 defined daily dose
Standard Deviation 2.04
|
0.97 defined daily dose
Standard Deviation 0.99
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 7
|
1.56 defined daily dose
Standard Deviation 2.44
|
—
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 8
|
0.66 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
—
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 9
|
2.11 defined daily dose
Standard Deviation 1.71
|
—
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 10
|
2.50 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
—
|
|
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 11
|
2.34 defined daily dose
Standard Deviation 2.35
|
—
|
SECONDARY outcome
Timeframe: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12Population: Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=11 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=7 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Directly after surgery
|
2.67 defined daily dose
Standard Deviation 0.89
|
6.94 defined daily dose
Standard Deviation 3.20
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 1
|
4.21 defined daily dose
Standard Deviation 6.24
|
10.50 defined daily dose
Standard Deviation 7.67
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 2
|
5.05 defined daily dose
Standard Deviation 6.86
|
10.50 defined daily dose
Standard Deviation 8.71
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 3
|
3.47 defined daily dose
Standard Deviation 2.79
|
20.00 defined daily dose
Standard Deviation 0
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 4
|
1.48 defined daily dose
Standard Deviation 0.87
|
20.00 defined daily dose
Standard Deviation 0
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 5
|
4.22 defined daily dose
Standard Deviation 3.85
|
14.78 defined daily dose
Standard Deviation 9.05
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 6
|
5.63 defined daily dose
Standard Deviation 3.96
|
13.83 defined daily dose
Standard Deviation 10.68
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 7
|
5.17 defined daily dose
Standard Deviation 3.48
|
14.00 defined daily dose
Standard Deviation 10.39
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 8
|
6.75 defined daily dose
Standard Deviation 7.42
|
15.83 defined daily dose
Standard Deviation 7.22
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 9
|
5.01 defined daily dose
Standard Deviation 5.20
|
16.00 defined daily dose
Standard Deviation 4.00
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 10
|
5.83 defined daily dose
Standard Deviation 4.86
|
12.00 defined daily dose
Standard Deviation 11.31
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 11
|
5.17 defined daily dose
Standard Deviation 5.42
|
20.00 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
|
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
Week 12
|
11.27 defined daily dose
Standard Deviation 15.18
|
27.00 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
SECONDARY outcome
Timeframe: Directly after surgery, 6 months, and 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=27 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=22 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
Directly after surgery
|
3.10 defined daily dose
Standard Deviation 7.53
|
7.82 defined daily dose
Standard Deviation 22.93
|
|
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
6 months
|
—
|
2.40 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
SECONDARY outcome
Timeframe: Directly after surgery, 6 months, and 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.
Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=11 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=7 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
Directly after surgery
|
2.67 defined daily dose
Standard Deviation 0.89
|
6.94 defined daily dose
Standard Deviation 3.20
|
|
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
6 months
|
19.00 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
3.20 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
|
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
12 months
|
2.00 defined daily dose
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available
|
—
|
SECONDARY outcome
Timeframe: Following index surgery, up to 7 weeksPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Duration of shoulder immobilization measured as days spent in a sling
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=50 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=53 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Duration of Shoulder Immobilization
|
35.72 days
Standard Deviation 12.55
|
18.40 days
Standard Deviation 14.55
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated. It was possible for participants to return to partial, modified, or part-time employment, and then return to fulltime employment within the 12 month period. Meaning, multiple responses were allowed.
Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as "Not currently employed", "Did not return to work", "Returned to partial, modified, or parttime employment", or "Returned to fulltime employment." The type of work for each work status (excluding "Not currently employed") was then categorized as: * Very heavy work * Heavy work * Medium work * Light work * Sedentary work
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=49 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=48 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Not currently employed
|
20 Participants
|
16 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Did not return to work : Very heavy work
|
0 Participants
|
0 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Did not return to work : Heavy work
|
0 Participants
|
0 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Did not return to work : Medium work
|
1 Participants
|
0 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Did not return to work : Light work
|
0 Participants
|
0 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Did not return to work : Sedentary work
|
0 Participants
|
0 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to partial, modified, or parttime employment : Very heavy work
|
0 Participants
|
0 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to partial, modified, or parttime employment : Heavy work
|
2 Participants
|
5 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to partial, modified, or parttime employment : Medium work
|
4 Participants
|
6 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to partial, modified, or parttime employment : Light work
|
3 Participants
|
3 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to partial, modified, or parttime employment : Sedentary work
|
3 Participants
|
2 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to fulltime employment : Very heavy work
|
0 Participants
|
2 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to fulltime employment : Heavy work
|
5 Participants
|
4 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to fulltime employment : Medium work
|
7 Participants
|
8 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to fulltime employment : Light work
|
7 Participants
|
10 Participants
|
|
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
Returned to fulltime employment : Sedentary work
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Following index surgery, up to 139 daysPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Time to return to driving post-index surgery measured in days.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=48 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=53 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Time to Return to Driving
|
24.54 days
Standard Deviation 19.85
|
18.3 days
Standard Deviation 21.60
|
SECONDARY outcome
Timeframe: Following index surgery, approximately 1 yearPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Time to return to sports involving overhead throwing post-index surgery measured in days.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=2 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=8 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Time to Return to Sports
|
93.50 days
Standard Deviation 17.68
|
202 days
Standard Deviation 87.18
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=48 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=49 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=Yes | Tendinosis
|
8 Participants
|
7 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=Yes | Low-grade Partial Thickness Tear
|
5 Participants
|
6 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=Yes | High-grade Partial Thickness Tear
|
5 Participants
|
7 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=Yes | Full-Thickness Tear
|
2 Participants
|
1 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=Yes | Intact
|
1 Participants
|
2 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=No | Tendinosis
|
7 Participants
|
5 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=No | Low-grade Partial Thickness Tear
|
6 Participants
|
12 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=No | High-grade Partial Thickness Tear
|
5 Participants
|
6 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=No | Full-Thickness Tear
|
0 Participants
|
0 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 12 Months
Bursal=No | Intact
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: * Tendinosis * Low-grade Partial Thickness Tear * High-grade Partial Thickness Tear * Full-Thickness Tear * Intact
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=21 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=47 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=Yes | Tendinosis
|
4 Participants
|
10 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=Yes | Low-grade Partial Thickness Tear
|
2 Participants
|
5 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=Yes | High-grade Partial Thickness Tear
|
2 Participants
|
3 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=Yes | Full-Thickness Tear
|
0 Participants
|
1 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=Yes | Intact
|
0 Participants
|
3 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=No | Tendinosis
|
4 Participants
|
5 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=No | Low-grade Partial Thickness Tear
|
6 Participants
|
13 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=No | High-grade Partial Thickness Tear
|
1 Participants
|
3 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=No | Full-Thickness Tear
|
0 Participants
|
0 Participants
|
|
Number of Participants With Progression to Full-Thickness Tear at 24 Months
Bursal=No | Intact
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100%
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=41 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=33 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=Yes | 0% to < 25%
|
3 Participants
|
1 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=Yes | 25% to < 50%
|
0 Participants
|
1 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=Yes | 50% to < 75%
|
1 Participants
|
2 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=Yes | 75% to < 100%
|
7 Participants
|
6 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=Yes | 100%
|
4 Participants
|
4 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=No | 0% to < 25%
|
4 Participants
|
1 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=No | 25% to < 50%
|
2 Participants
|
5 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=No | 50% to < 75%
|
3 Participants
|
2 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=No | 75% to < 100%
|
6 Participants
|
10 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 12 Months
Bursal=No | 100%
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following: * 0% to \< 25% * 25% to \< 50% * 50% to \< 75% * 75% to \<100% * 100%
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=20 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=33 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=No | 100%
|
5 Participants
|
2 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=Yes | 0% to < 25%
|
3 Participants
|
0 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=Yes | 25% to < 50%
|
0 Participants
|
0 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=Yes | 50% to < 75%
|
1 Participants
|
0 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=Yes | 75% to < 100%
|
3 Participants
|
6 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=Yes | 100%
|
1 Participants
|
7 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=No | 0% to < 25%
|
0 Participants
|
2 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=No | 25% to < 50%
|
1 Participants
|
3 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=No | 50% to < 75%
|
1 Participants
|
3 Participants
|
|
Number of Participants Percent Filling of Rotator Cuff at 24 Months
Bursal=No | 75% to < 100%
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated)
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=47 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=47 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Rotator Cuff Tendon Thickness at 12 Months
Total Thickness (where tendon thickness cannot be differentiated)
|
4.57 millimeters (mm)
Standard Deviation 1.75
|
4.45 millimeters (mm)
Standard Deviation 1.86
|
|
Rotator Cuff Tendon Thickness at 12 Months
Thickness of Native (where tendon thickness can be differentiated)
|
1.87 millimeters (mm)
Standard Deviation 1.13
|
3.50 millimeters (mm)
Standard Deviation 0.85
|
|
Rotator Cuff Tendon Thickness at 12 Months
Thickness of New Tissue (where tendon thickness can be differentiated)
|
2.53 millimeters (mm)
Standard Deviation 0.79
|
2.40 millimeters (mm)
Standard Deviation 0.42
|
|
Rotator Cuff Tendon Thickness at 12 Months
Total Thickness (where tendon thickness can be differentiated)
|
4.40 millimeters (mm)
Standard Deviation 1.60
|
5.90 millimeters (mm)
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as: * Total Thickness (where tendon thickness cannot be differentiated) * Thickness of Native (where tendon thickness can be differentiated) * Thickness of New Tissue (where tendon thickness can be differentiated) * Total Thickness (where tendon thickness can be differentiated)
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=21 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=46 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Rotator Cuff Tendon Thickness at 24 Months
Total Thickness (where tendon thickness cannot be differentiated)
|
4.63 millimeters (mm)
Standard Deviation 1.47
|
4.88 millimeters (mm)
Standard Deviation 1.90
|
|
Rotator Cuff Tendon Thickness at 24 Months
Thickness of Native (where tendon thickness can be differentiated)
|
2.80 millimeters (mm)
Standard Deviation 1.13
|
4.00 millimeters (mm)
Standard Deviation 0.91
|
|
Rotator Cuff Tendon Thickness at 24 Months
Thickness of New Tissue (where tendon thickness can be differentiated)
|
2.90 millimeters (mm)
Standard Deviation 0.85
|
2.38 millimeters (mm)
Standard Deviation 0.41
|
|
Rotator Cuff Tendon Thickness at 24 Months
Total Thickness (where tendon thickness can be differentiated)
|
5.70 millimeters (mm)
Standard Deviation 0.28
|
6.38 millimeters (mm)
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=48 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=49 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=No | Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=Yes | Grade 1
|
13 Participants
|
15 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=Yes | Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=Yes | Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=Yes | Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=Yes | Grade 0
|
6 Participants
|
7 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=No | Grade 1
|
16 Participants
|
12 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=No | Grade 2
|
4 Participants
|
3 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=No | Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
Bursal=No | Grade 0
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Grade 1 * Grade 2 * Grade 3 * Grade 4 * Grade 0
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=21 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=47 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=Yes | Grade 1
|
6 Participants
|
13 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=Yes | Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=Yes | Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=Yes | Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=Yes | Grade 0
|
2 Participants
|
8 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=No | Grade 1
|
7 Participants
|
11 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=No | Grade 2
|
3 Participants
|
3 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=No | Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=No | Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
Bursal=No | Grade 0
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=47 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=47 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=Yes | Type I
|
4 Participants
|
4 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=Yes | Type II
|
8 Participants
|
8 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=Yes | Type III
|
6 Participants
|
8 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=Yes | Type IV
|
2 Participants
|
1 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=Yes | Type V
|
0 Participants
|
0 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=No | Type I
|
11 Participants
|
6 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=No | Type II
|
10 Participants
|
12 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=No | Type III
|
6 Participants
|
8 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=No | Type IV
|
0 Participants
|
0 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 12 Months
Bursal=No | Type V
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: * Type I * Type II * Type III * Type IV * Type V
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=21 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=45 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=Yes | Type I
|
1 Participants
|
5 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=Yes | Type II
|
5 Participants
|
10 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=Yes | Type III
|
2 Participants
|
4 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=Yes | Type IV
|
0 Participants
|
1 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=Yes | Type V
|
0 Participants
|
0 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=No | Type I
|
3 Participants
|
7 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=No | Type II
|
8 Participants
|
14 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=No | Type III
|
2 Participants
|
4 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=No | Type IV
|
0 Participants
|
0 Participants
|
|
Number of Participants Sugaya Score of Rotator Cuff at 24 Months
Bursal=No | Type V
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Following index surgery, up to 24 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Participants With Revision Surgery
Revision Surgery: Yes
|
4 Participants
|
1 Participants
|
|
Number of Participants With Revision Surgery
Revision Surgery: No
|
55 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Following index surgery, up to 12 monthsPopulation: Appropriate data not collected to perform analysis as a result of study termination
Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intra-operativePopulation: Overall number of participants with available data for the treatment and time frame indicated.
Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 Participants
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=55 Participants
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Operating Room Time (Index Surgery)
|
57.05 minutes
Standard Deviation 19.16
|
46.89 minutes
Standard Deviation 19.13
|
SECONDARY outcome
Timeframe: Following index surgery, up to 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=16 injections
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=19 injections
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Steroid Injections
|
1.60 injections
Standard Deviation 1.00
|
1.58 injections
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Following index surgery, up to 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record.
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=232 unscheduled visits
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=214 unscheduled visits
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Unscheduled Clinic Visits
|
5.16 unscheduled visits
Standard Deviation 2.08
|
4.1 unscheduled visits
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Following index surgery, up to 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=15 for-cause imaging procedures
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=25 for-cause imaging procedures
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of For-Cause Imaging Procedures
|
1.50 for-cause imaging procedures
Standard Deviation 0.85
|
2.27 for-cause imaging procedures
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Following index surgery, up to 12 monthsPopulation: Overall number of participants with available data for the treatment and time frame indicated.
The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record
Outcome measures
| Measure |
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=1253 physiotherapy sessions
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
REGENETEN™ Bioinductive Implant
n=773 physiotherapy sessions
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
|---|---|---|
|
Number of Physiotherapy Sessions
|
27.84 physiotherapy sessions
Standard Deviation 13.41
|
18.40 physiotherapy sessions
Standard Deviation 8.23
|
Adverse Events
REGENETEN™ Bioinductive Implant
Serious events: 33 serious events
Other events: 51 other events
Deaths: 0 deaths
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
Serious events: 17 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
REGENETEN™ Bioinductive Implant
n=59 participants at risk
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 participants at risk
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia in Relapse
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Acute Pyelonephritis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure and covid-19 pneumonia
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure, pneumonia, and left pleural effusion
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Adhesive capsulitis left shoulder
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Cardiac disorders
atherosclerotic occlusive coronary artery disease
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Avascular Necrosis {left shoulder, hip, ankle with concomitant medial malleolar stress fracture}
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Candidal Skin Infection
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Cellulitis of Right Upper Extremity
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
General disorders
Chemotherapy Induced Nausea
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
COVID-19 (Hospitalization)
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Covid-19, Pneumonia
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Cytomegalovirus
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Vascular disorders
Deep Vein Thrombosis and Superficial Venous Thrombosis of Left Upper Extremity
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Gastrointestinal disorders
epigastric pain with vomiting; anal fistula
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Failure of Left total knee replacement, subsequent encounter
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Failure of RIGHT total knee replacement, subsequent encounter
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Immune system disorders
Graft vs Host Disease
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
infection of left elbow
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Labial Lesion
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Knee internal derangement of posterior horn medial meniscus
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left knee tibial plateau fracture
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
left lower extremity cellulitis status post coronary artery bypass
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
left shoulder arthrofibrosis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
left shoulder pain
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Left shoulder partial rotator cuff tear (non-study arm)
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Cardiac disorders
Left Side Pulmonary Embolism
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Pulmonary Nodules/Lesions
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Immune system disorders
Neutropenic Fever
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Endocrine disorders
Noninsulin Dependent Diabetes Mellitus with Hyperglycemia
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Cardiac disorders
Non-ST Elevation Myocardial Infarction
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia due to Chemotherapy
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Planned Hospital admission for FLU/CY/TBI Haplo AllSCT for AML
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Planned Hospital admit for Cycle 1 of HiDose APA-c
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Postprocedural Bulbous Urethral Stricture
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Vascular disorders
Pulmonary Embolism
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Gastrointestinal disorders
revision repair of ventral incisional hernia
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Anterior supraspinatus recurrent supraspinatus tear status post prior repair
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right carpal tunnel syndrome and right trigger thumb
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right deltoid muscle strain progressed to rotator cuff re-tear
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Blood and lymphatic system disorders
Right Knee Anteromedial Osteoarthritis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right rotator cuff repair revision with bicep repair
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Rotator cuff tear
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Right Shoulder Pain Status post Fall
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Metabolism and nutrition disorders
Severe iron deficiency anemia requiring blood transfusion
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Surgical and medical procedures
Unknown dental issue requiring tooth extraction
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Vascular disorders
unstable angina
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Ureteral Calculus
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
3.4%
2/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Gastrointestinal disorders
ventral hernia
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
Other adverse events
| Measure |
REGENETEN™ Bioinductive Implant
n=59 participants at risk
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
|
Arthroscopic Repair of the High-grade (>50%) Partial-thickness
n=59 participants at risk
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
|
|---|---|---|
|
Infections and infestations
Abscess of Right Axilla
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Acute Costochondritis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Immune system disorders
Allergic Reaction of unknown origin -Likely food related
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
alopecia
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Back muscle strain
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral biceps tendinitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Nervous system disorders
Bilateral Headaches
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral Shoulder Pain
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Eye disorders
Blurry Vision
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis and sinus infection
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Nervous system disorders
chronic regional pain syndrome
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
chronic right shoulder pain status post fall, possible adhesive capsulitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Clostridioides Difficile Diarrhea
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Surgical and medical procedures
Colonoscopy to determine cause of increased diarrhea and stomach pain
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
contact dermatitis from surgical tape
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
General disorders
cough, diarrhea, muscle pain, weakness
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
COVID-19
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
6.8%
4/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
decrease range of motion right shoulder
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
dermatitis from surgical bandages
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Ear and labyrinth disorders
Dizziness
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Due to dehydration, patient fell. She had mild soreness in index shoulder.
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Hepatobiliary disorders
Elevated liver enzymes - fatty liver
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Gastrointestinal disorders
Food poisoning/stomach infection/inflamed intestines
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Fractured Rib after Fall
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Gout Flare up to Left Ankle
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Gross Hematuria
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
hematuria
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Herpes Simplex Virus Infection ( Right Upper Lip)
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Increased left bicep and shoulder pain after increased PT/"bursitis" type symptoms
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Increased left shoulder pain after fall into wall
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Increased left shoulder pain after overuse
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Increased left shoulder pain after slipping in shower and grabbing bar with left arm.
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Increased left shoulder pain, especially when lifting arm out to the side
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Increased left shoulder stiffness and pain
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
left AC Joint pain
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Adhesive Capsulitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left foot arthritis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left mild tendinopathy
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
left rotator cuff tendonitis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left shoulder biceps tendonitis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left shoulder bursitis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left shoulder impingement
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
left shoulder osteoarthritis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
left shoulder pain
|
3.4%
2/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
5.1%
3/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Left shoulder pain after napping without sling
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
left shoulder pain from fall
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
6.8%
4/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
left shoulder pain secondary to a partial thickness bursal sided rotator cuff retear
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left shoulder soreness/pain when raising arm to mid-chest level
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left wrist pain with numbness in fingers. Carpal tunnel-like symptoms.
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
lumbar pain
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Lyme disease
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Mucositis due to Antineoplastic Therapy
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps in left shoulder
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain around left mid-scapular border
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
new onset pain and motion loss left shoulder due to over-exerting left shoulder
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain under right arm, in armpit area
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Patient Fall
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
Patient felt a pop and acute increased pain in right shoulder
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Nervous system disorders
Peripheral Neuropathy
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Nervous system disorders
primary headache syndrome
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Pseudomonas Urinary Tract Infection
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash in Adult located on Left Scapula area
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Respiratory Syncytial Virus
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right acromioclavicular Joint arthritris
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Adhesive Capsulitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right biceps tendonitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Renal and urinary disorders
Right Flank Pain
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right great toe stress fracture
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right hand gamekeeper's thumb
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right hip bursitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right knee osteoarthritis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right partial thickness rotator cuff tear
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right shoulder AC Joint osteoarthritis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Adhesive Capsulitis
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Adhesive Capsulitis/ anterior shoulder pain (impingement)
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right shoulder impingement syndrome
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right shoulder pain
|
6.8%
4/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
3.4%
2/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right shoulder pain due to flare up of biceps tenotomy
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Injury, poisoning and procedural complications
right shoulder pain from fall
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain from physical therapy
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
right shoulder stiffness
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right shoulder tendinosis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right thumb trigger finger
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Right Upper Extremity Hematoma
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Nervous system disorders
Sciatica down right leg
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion on right foot 4th toe
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Nervous system disorders
Tremors of right upper extremity
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Reproductive system and breast disorders
Unspecified Lump in the Left Breast
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Reproductive system and breast disorders
Vaginitis
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Cardiac disorders
Vasovagal episode/fall causing broken nose
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
|
Infections and infestations
Yeast infection
|
0.00%
0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
1.7%
1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right to modify any proposed publication within 30 days after receipt if it discloses potentially patentable items, patent, trade secret, or other proprietary or confidential information of Sponsor. If patentable items are involved, proposed, disclosure to third party may be delayed up to 90 days. If not submitted within 18 months after the Study's conclusion, the Site/Investigator may publish results after Sponsor's review.
- Publication restrictions are in place
Restriction type: OTHER