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Trial Outcomes & Findings for Safety of Treatment of Shoulder Repair (NCT NCT04552119)

NCT ID: NCT04552119

Last Updated: 2026-04-16

Results Overview

Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.

Recruitment status

COMPLETED

Target enrollment

138 participants

Primary outcome timeframe

6 months

Results posted on

2026-04-16

Participant Flow

Participant milestones

Participant milestones
Measure
HEALICOIL Knotless PEEK
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Overall Study
STARTED
66
72
Overall Study
COMPLETED
51
58
Overall Study
NOT COMPLETED
15
14

Reasons for withdrawal

Reasons for withdrawal
Measure
HEALICOIL Knotless PEEK
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Overall Study
Adverse Event
1
0
Overall Study
Lost to Follow-up
10
11
Overall Study
Withdrawal by Subject
4
3

Baseline Characteristics

Data necessary for BMI not collected for 11 participants in HEALICOIL Knotless REGENESORB and will not be reported.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HEALICOIL Knotless PEEK
n=66 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=72 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Total
n=138 Participants
Total of all reporting groups
Sex: Female, Male
Female
26 Participants
n=66 Participants
37 Participants
n=72 Participants
63 Participants
n=138 Participants
Sex: Female, Male
Male
40 Participants
n=66 Participants
35 Participants
n=72 Participants
75 Participants
n=138 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=66 Participants
8 Participants
n=72 Participants
11 Participants
n=138 Participants
Age, Continuous
57.4 years
STANDARD_DEVIATION 9.10 • n=66 Participants
59.6 years
STANDARD_DEVIATION 8.75 • n=72 Participants
58.60 years
STANDARD_DEVIATION 8.95 • n=138 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants
n=66 Participants
63 Participants
n=72 Participants
126 Participants
n=138 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=66 Participants
1 Participants
n=72 Participants
1 Participants
n=138 Participants
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
0 Participants
n=66 Participants
1 Participants
n=72 Participants
1 Participants
n=138 Participants
Race/Ethnicity, Customized
Race · Asian
4 Participants
n=66 Participants
0 Participants
n=72 Participants
4 Participants
n=138 Participants
Race/Ethnicity, Customized
Race · Black or African American
2 Participants
n=66 Participants
2 Participants
n=72 Participants
4 Participants
n=138 Participants
Race/Ethnicity, Customized
Race · White
57 Participants
n=66 Participants
63 Participants
n=72 Participants
120 Participants
n=138 Participants
Race/Ethnicity, Customized
Race · Other
3 Participants
n=66 Participants
6 Participants
n=72 Participants
9 Participants
n=138 Participants
Region of Enrollment
United States
66 participants
n=66 Participants
72 participants
n=72 Participants
138 participants
n=138 Participants
Body Mass Index (BMI)
30.0 kg/m^2
STANDARD_DEVIATION 5.61 • n=66 Participants • Data necessary for BMI not collected for 11 participants in HEALICOIL Knotless REGENESORB and will not be reported.
30.1 kg/m^2
STANDARD_DEVIATION 6.11 • n=61 Participants • Data necessary for BMI not collected for 11 participants in HEALICOIL Knotless REGENESORB and will not be reported.
30.0 kg/m^2
STANDARD_DEVIATION 5.83 • n=127 Participants • Data necessary for BMI not collected for 11 participants in HEALICOIL Knotless REGENESORB and will not be reported.
Type of HEALICOIL Knotless Suture Anchor
Self-Tapping
34 Participants
n=66 Participants
37 Participants
n=72 Participants
71 Participants
n=138 Participants
Type of HEALICOIL Knotless Suture Anchor
Non-Self Tapping
32 Participants
n=66 Participants
35 Participants
n=72 Participants
67 Participants
n=138 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Safety population (SAF) included participants that received the study device with data collected for the time frame specified.

Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=58 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Clinical Success Rate at 6 Months
58 Participants
68 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Safety population (SAF) included participants that received the study device with data collected for the time frame specified.

Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=51 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=63 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Clinical Success Rate at 12 Months
51 Participants
63 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Safety population (SAF) included participants with data collected for the study device indicated. Data collection at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data at 24 months was only reported for HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor participants with data collected)

Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=27 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY)
27 Participants
—

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, and 24 months

Population: Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only).

Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology across four domains of pain, activities of daily living (ADL), range of motion (ROM), and strength. Pain and ADL are answered by the participant. ROM and strength require a physical evaluation and are answered by the surgeon or the physiotherapist. Scores range from 0 to 100, with a higher score indicating better shoulder function (i.e., a better outcome).

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=57 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Constant-Murley Score
Baseline
48.02 score on a scale
Standard Deviation 19.01
44.93 score on a scale
Standard Deviation 12.87
Constant-Murley Score
6 months
73.58 score on a scale
Standard Deviation 10.59
67.94 score on a scale
Standard Deviation 8.88
Constant-Murley Score
12 months
79.43 score on a scale
Standard Deviation 9.64
74.40 score on a scale
Standard Deviation 10.69
Constant-Murley Score
24 months
—
77.32 score on a scale
Standard Deviation 9.13

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, and 24 months

Population: Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only).

The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is 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). The ASES score ranges from 0 to 100 with a higher score indicating improvement in pain and function (i.e., a better outcome).

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=58 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
American Shoulder and Elbow Surgeons (ASES) Score
Baseline
49.83 score on a scale
Standard Deviation 19.99
46.13 score on a scale
Standard Deviation 18.31
American Shoulder and Elbow Surgeons (ASES) Score
6 months
85.45 score on a scale
Standard Deviation 11.85
83.79 score on a scale
Standard Deviation 16.21
American Shoulder and Elbow Surgeons (ASES) Score
12 months
93.14 score on a scale
Standard Deviation 11.24
89.63 score on a scale
Standard Deviation 13.89
American Shoulder and Elbow Surgeons (ASES) Score
24 months
—
91.54 score on a scale
Standard Deviation 16.51

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, and 24 months

Population: Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only).

The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is 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). The ASES VAS Pain score ranges from 0 to 10, where 0 represented no pain and 10 represented the worst pain (i.e., a lower score is a better outcome).

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=58 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score
Baseline
5.24 score on a scale
Standard Deviation 2.91
5.94 score on a scale
Standard Deviation 2.57
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score
6 months
1.73 score on a scale
Standard Deviation 1.95
1.79 score on a scale
Standard Deviation 2.21
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score
12 months
0.90 score on a scale
Standard Deviation 1.62
1.34 score on a scale
Standard Deviation 1.85
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score
24 months
—
1.22 score on a scale
Standard Deviation 2.53

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, and 24 months

Population: Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. The 24-month time frame only applied to participants receiving HEALICOIL Knotless Suture REGENESORB Non-Self Tapping suture anchor (i.e., data not reported at 24 months for HEALICOIL Knotless PEEK because it was not collected per the protocol).

The SANE is a simple, single-question, patient-based shoulder function assessment tool based on responses to the question ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' Scores ranged from 0 to 100, where 100 was considered normal (i.e., a better outcome).

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=58 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months
Baseline
48.93 score on a scale
Standard Deviation 21.61
45.59 score on a scale
Standard Deviation 25.06
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months
6 months
86.71 score on a scale
Standard Deviation 13.19
86.31 score on a scale
Standard Deviation 12.03
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months
12 months
94.22 score on a scale
Standard Deviation 7.40
93.03 score on a scale
Standard Deviation 10.24
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months
24 months
—
94.04 score on a scale
Standard Deviation 8.94

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, and 24 months

Population: Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only).

The EuroQol EQ-5D-3L is composed of a descriptive system and EQ Visual Analogue Scale (EQ VAS). The descriptive system measures health-related Quality of Life (QOL) that consists of five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored based on one of the three levels of severity (e.g., no problems, some or moderate problems, extreme problems) to create a combined Index Score. The Index Score is reported on a scale of 0 to 1 with a higher score indicating better health.

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=58 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score
Baseline
0.82 score on a scale
Standard Deviation 0.07
0.81 score on a scale
Standard Deviation 0.07
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score
6 months
0.93 score on a scale
Standard Deviation 0.08
0.91 score on a scale
Standard Deviation 0.09
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score
12 months
0.95 score on a scale
Standard Deviation 0.08
0.94 score on a scale
Standard Deviation 0.08
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score
24 months
—
0.96 score on a scale
Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, and 24 months

Population: Full Analysis Set (FAS) population followed the intention-to-treat principle for participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame specified. Data reported at 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported at 24 months is the data collected for Non-Self Tapping Suture Anchor participants only).

The EuroQol EQ-5D-3L is composed of the descriptive system and EQ Visual Analogue Scale (EQ VAS). The EQ VAS was the participants self-rated health scored on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome).

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=58 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=68 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score
Baseline
76.81 score on a scale
Standard Deviation 14.81
71.78 score on a scale
Standard Deviation 19.58
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score
6 months
86.06 score on a scale
Standard Deviation 9.59
81.82 score on a scale
Standard Deviation 12.97
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score
12 months
84.65 score on a scale
Standard Deviation 17.60
83.77 score on a scale
Standard Deviation 13.48
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score
24 months
—
90.59 score on a scale
Standard Deviation 9.59

SECONDARY outcome

Timeframe: 6 months and 24 months

Population: Safety Analysis (SAF) population included participants receiving the indicated study device with data collected for the time frame specified. MRI Data reported at 6 months and 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported is the data collected for Non-Self Tapping Suture Anchor participants only).

Magnetic Resonance Imaging (MRI) was used to determine tendon thickening in millimeters (mm) for the supraspinatus tendon at the Lateral Anterior, Lateral Posterior, Medial Anterior, and Medial Posterior locations at 6 months and 24 months. Lateral measurements were taken from the lateral end of the supraspinatus tendon, about 5mm to the bony insertion site. Medial measurements considered the medial end of the supraspinatus tendon, about 5mm lateral to the musculotendinous junction.

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=28 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
6 months: Medial Posterior
6.0 millimeters (mm)
Standard Deviation 1.11
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
24 months: Lateral Anterior
5.5 millimeters (mm)
Standard Deviation 0.94
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
24 months: Lateral Posterior
6.1 millimeters (mm)
Standard Deviation 1.21
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
24 months: Medial Anterior
5.3 millimeters (mm)
Standard Deviation 0.89
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
24 months: Medial Posterior
5.0 millimeters (mm)
Standard Deviation 1.01
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
6 months: Lateral Anterior
6.5 millimeters (mm)
Standard Deviation 1.31
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
6 months: Lateral Posterior
6.3 millimeters (mm)
Standard Deviation 1.16
—
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
6 months: Medial Anterior
6.6 millimeters (mm)
Standard Deviation 1.59
—

SECONDARY outcome

Timeframe: 6 months and 24 months

Population: Safety Analysis (SAF) population included participants receiving the indicated study device with data collected for the time frame specified. MRI Data reported at 6 months and 24 months only applied to participants receiving the HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor type as specified in the protocol (i.e., data reported is the data collected for Non-Self Tapping Suture Anchor participants only).

Magnetic Resonance Imaging (MRI) was used to determine participant tendon Re-tear Status at 6 months and 24 months. Re-tear Status was categorized as either 'Absent' or 'Present' based on the Re-tear Type assessment. 'Absent' indicated a Re-tear Type graded as 'Intact', 'Low-grade Partial-Thickness Tear', or 'High-grade Partial-Thickness Tear'. 'Present' indicated a Re-tear Type graded as 'Full-Thickness Tear'.

Outcome measures

Outcome measures
Measure
HEALICOIL Knotless PEEK
n=30 Participants
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
6 months · Absent
25 Participants
—
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
6 months · Present
5 Participants
—
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
24 months · Absent
17 Participants
—
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
24 months · Present
5 Participants
—

Adverse Events

HEALICOIL Knotless PEEK

Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths

HEALICOIL Knotless REGENESORB

Serious events: 14 serious events
Other events: 32 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
HEALICOIL Knotless PEEK
n=66 participants at risk
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=72 participants at risk
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Musculoskeletal and connective tissue disorders
ARTHRITIS
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
BONE FRACTURE(S)
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
DAMAGE TO LIGAMENT(S)
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
MUSCLE/TENDON DAMAGE
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
2.8%
2/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
UNSPECIFIED MUSCULOSKELETAL PROBLEM
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Injury, poisoning and procedural complications
BONE FRACTURE(S)
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Injury, poisoning and procedural complications
RUPTURE
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
PAIN
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
2.8%
2/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
NERVE DAMAGE
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
HEMORRHAGIC STROKE
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Vascular disorders
ARTERIOSCLEROSIS/ ATHEROSCLEROSIS
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Cardiac disorders
UNSPECIFIED HEART PROBLEM
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Respiratory, thoracic and mediastinal disorders
NASAL OBSTRUCTION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Eye disorders
CATARACT
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
4.2%
3/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Gastrointestinal disorders
UNSPECIFIED GASTROINTESTINAL PROBLEM
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.

Other adverse events

Other adverse events
Measure
HEALICOIL Knotless PEEK
n=66 participants at risk
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK: HEALICOIL Knotless PEEK Self-Tapping or HEALICOIL Knotless PEEK Non-Self Tapping
HEALICOIL Knotless REGENESORB
n=72 participants at risk
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB: HEALICOIL Knotless REGENESORB Self-Tapping or HEALICOIL Knotless REGENESORB Non-Self Tapping
Nervous system disorders
DIZZINESS
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
HEADACHE
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
SYNCOPE/FAINTING
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
SHAKING/TREMORS
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
NERVE DAMAGE
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
NEUROPATHY
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
SLEEP DYSFUNCTION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
SPEECH DISORDER
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Nervous system disorders
STROKE/CVA
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Psychiatric disorders
ANXIETY
3.0%
2/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Immune system disorders
LOCAL REACTION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Vascular disorders
ANEURYSM
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Cardiac disorders
VALVULAR STENOSIS
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Respiratory, thoracic and mediastinal disorders
ASTHMA
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Respiratory, thoracic and mediastinal disorders
COUGH
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT INFECTION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
2.8%
2/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Respiratory, thoracic and mediastinal disorders
UNSPECIFIED RESPIRATORY PROBLEM
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Ear and labyrinth disorders
PARTIAL HEARING LOSS
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
ABDOMINAL PAIN
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Gastrointestinal disorders
CONSTIPATION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Gastrointestinal disorders
DIARRHEA
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Gastrointestinal disorders
NAUSEA
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Gastrointestinal disorders
VOMITING
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Gastrointestinal disorders
UNSPECIFIED GASTROINTESTINAL PROBLEM
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Renal and urinary disorders
URINARY FREQUENCY
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Reproductive system and breast disorders
INTERMENSTRUAL BLEEDING
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
ARTHRITIS
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
5.6%
4/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
CRAMP(S) /MUSCLE SPASM(S)
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
2.8%
2/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
4.2%
3/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
MUSCLE/TENDON DAMAGE
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
2.8%
2/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
OSTEOPENIA/ OSTEOPOROSIS
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
SPINAL COLUMN INJURY
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Musculoskeletal and connective tissue disorders
UNSPECIFIED MUSCULOSKELETAL PROBLEM
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Skin and subcutaneous tissue disorders
ITCHING SENSATION
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Skin and subcutaneous tissue disorders
LOCALIZED SKIN LESION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CYST(S)
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NODULE
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
0.00%
0/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Infections and infestations
VIRAL INFECTION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
4.2%
3/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Injury, poisoning and procedural complications
LACERATION(S)
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Injury, poisoning and procedural complications
RUPTURE
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Injury, poisoning and procedural complications
ADHESION(S)
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
Injury, poisoning and procedural complications
POST OPERATIVE WOUND INFECTION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
HIGH BLOOD PRESSURE/ HYPERTENSION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
INFLAMMATION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
4.2%
3/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
OBSTRUCTION/OCCLUSION
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
1.4%
1/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
PAIN
1.5%
1/66 • Adverse events were collected during surgery to study completion, up to 24 months.
4.2%
3/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
SWELLING/ EDEMA
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
4.2%
3/72 • Adverse events were collected during surgery to study completion, up to 24 months.
General disorders
APPROPRIATE TERM / CODE NOT AVAILABLE
0.00%
0/66 • Adverse events were collected during surgery to study completion, up to 24 months.
2.8%
2/72 • Adverse events were collected during surgery to study completion, up to 24 months.

Additional Information

Senior Manager Clinical Compliance

Smith+Nephew, Inc

Phone: 18008215700

Results disclosure agreements

  • Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 90 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
  • Publication restrictions are in place

Restriction type: OTHER