Trial Outcomes & Findings for A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder (NCT NCT05844930)
NCT ID: NCT05844930
Last Updated: 2026-03-05
Results Overview
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. The change in score is reported as \[(SPADI at Week 4) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.
COMPLETED
PHASE4
56 participants
Baseline, Week 4
2026-03-05
Participant Flow
Of the 56 participants enrolled, 3 were screen failures and 1 participant withdrew prior to randomization; therefore, 52 participants were randomized.
Participant milestones
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was only collected from participants who attended the visit where PROM was measured.
Baseline characteristics by cohort
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=27 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
59 years
STANDARD_DEVIATION 10.0 • n=25 Participants
|
57 years
STANDARD_DEVIATION 9.9 • n=52 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=27 Participants
|
13 Participants
n=25 Participants
|
30 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=27 Participants
|
12 Participants
n=25 Participants
|
22 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=27 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=27 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=27 Participants
|
20 Participants
n=25 Participants
|
41 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=27 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=52 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
25 participants
n=25 Participants
|
52 participants
n=52 Participants
|
|
Body Mass Index (BMI)
|
28.3 kg/m^2
STANDARD_DEVIATION 6.03 • n=27 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.69 • n=25 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 5.81 • n=52 Participants
|
|
Number of Participants who Use Tobacco or Vape Products
No
|
26 Participants
n=27 Participants
|
23 Participants
n=25 Participants
|
49 Participants
n=52 Participants
|
|
Number of Participants who Use Tobacco or Vape Products
Yes
|
1 Participants
n=27 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=52 Participants
|
|
Affected Side
Right
|
9 Participants
n=27 Participants
|
10 Participants
n=25 Participants
|
19 Participants
n=52 Participants
|
|
Affected Side
Left
|
18 Participants
n=27 Participants
|
15 Participants
n=25 Participants
|
33 Participants
n=52 Participants
|
|
Duration of Pain
< 6 months
|
13 Participants
n=27 Participants
|
14 Participants
n=25 Participants
|
27 Participants
n=52 Participants
|
|
Duration of Pain
6 months to 1 year
|
8 Participants
n=27 Participants
|
10 Participants
n=25 Participants
|
18 Participants
n=52 Participants
|
|
Duration of Pain
≥ 1 year
|
6 Participants
n=27 Participants
|
1 Participants
n=25 Participants
|
7 Participants
n=52 Participants
|
|
Number of participants who received prior treatment for this episode of shoulder pain
No
|
23 Participants
n=27 Participants
|
21 Participants
n=25 Participants
|
44 Participants
n=52 Participants
|
|
Number of participants who received prior treatment for this episode of shoulder pain
Yes
|
4 Participants
n=27 Participants
|
4 Participants
n=25 Participants
|
8 Participants
n=52 Participants
|
|
Shoulder Pain and Disability Index (SPADI)
|
59.1 Score on a scale
STANDARD_DEVIATION 23.82 • n=27 Participants
|
57.4 Score on a scale
STANDARD_DEVIATION 21.46 • n=25 Participants
|
58.3 Score on a scale
STANDARD_DEVIATION 22.51 • n=52 Participants
|
|
Pain Intensity as assessed by the Visual Analog Scale (VAS)
|
6.7 mm
STANDARD_DEVIATION 2.55 • n=27 Participants
|
7.0 mm
STANDARD_DEVIATION 2.44 • n=25 Participants
|
6.8 mm
STANDARD_DEVIATION 2.48 • n=52 Participants
|
|
American shoulder and elbow surgeons (ASES) score
|
39.8 Score on a scale
STANDARD_DEVIATION 21.19 • n=27 Participants
|
40.6 Score on a scale
STANDARD_DEVIATION 18.24 • n=25 Participants
|
40.2 Score on a scale
STANDARD_DEVIATION 19.64 • n=52 Participants
|
|
Passive Range of Motion (PROM) - Abduction Internal Rotation
|
23.9 degrees
STANDARD_DEVIATION 26.62 • n=26 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
29.9 degrees
STANDARD_DEVIATION 25.05 • n=25 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
26.8 degrees
STANDARD_DEVIATION 25.78 • n=51 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
|
Passive Range of Motion (PROM) - Abduction external rotation
|
44.5 degrees
STANDARD_DEVIATION 30.59 • n=26 Participants • Data was only collected form participants who attended the visit where PROM was measured.
|
34.9 degrees
STANDARD_DEVIATION 27.29 • n=25 Participants • Data was only collected form participants who attended the visit where PROM was measured.
|
39.8 degrees
STANDARD_DEVIATION 29.13 • n=51 Participants • Data was only collected form participants who attended the visit where PROM was measured.
|
|
Passive range of motion (PROM) - Forward Elevation
|
113.8 degrees
STANDARD_DEVIATION 27.87 • n=26 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
103.0 degrees
STANDARD_DEVIATION 37.83 • n=25 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
108.5 degrees
STANDARD_DEVIATION 33.25 • n=51 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
|
Passive Range of Motion (PROM) - Abduction
|
86.7 degrees
STANDARD_DEVIATION 18.60 • n=26 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
81.8 degrees
STANDARD_DEVIATION 20.46 • n=25 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
84.3 degrees
STANDARD_DEVIATION 19.49 • n=51 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
|
Passive Range of Motion (PROM) - Neutral External Rotation
|
28.5 degrees
STANDARD_DEVIATION 20.34 • n=26 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
30.2 degrees
STANDARD_DEVIATION 18.57 • n=25 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
29.3 degrees
STANDARD_DEVIATION 19.31 • n=51 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
|
Passive Range of Motion (PROM) - Neutral Internal Rotation
|
88.9 degrees
STANDARD_DEVIATION 16.19 • n=26 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
73.0 degrees
STANDARD_DEVIATION 28.89 • n=25 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
81.1 degrees
STANDARD_DEVIATION 24.42 • n=51 Participants • Data was only collected from participants who attended the visit where PROM was measured.
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 questionnaire.
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. The change in score is reported as \[(SPADI at Week 4) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=23 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI)
|
-37.8 score on a scale
Standard Deviation 22.49
|
-9.5 score on a scale
Standard Deviation 17.69
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 questionnaire.
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. The change in score is reported as \[(SPADI at Week 12) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=23 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI)
|
-38.4 score on a scale
Standard Deviation 26.92
|
-27.7 score on a scale
Standard Deviation 20.85
|
PRIMARY outcome
Timeframe: Baseline, week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 questionnaire.
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. The change in score is reported as \[(SPADI at 6 months) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI)
|
-37.7 score on a scale
Standard Deviation 30.12
|
-40.4 score on a scale
Standard Deviation 18.81
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 questionnaire.
Visual Analog Scale (VAS) is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. The change in pain intensity will be reported as \[(VAS at week 4) - (VAS at baseline)\] - a negative value indicates a decrease in pain intensity.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=23 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
|
-4.1 mm
Standard Deviation 2.56
|
-2.4 mm
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 questionnaire.
Visual Analog Scale (VAS) is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. The change in pain intensity will be reported as \[(VAS at week 12) - (VAS at baseline)\] - a negative value indicates a decrease in pain intensity.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=23 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
|
-3.9 mm
Standard Deviation 2.70
|
-3.4 mm
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: Baseline, week 24Visual Analog Scale (VAS) is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. The change in pain intensity will be reported as \[(VAS at 6 months) - (VAS at baseline)\] - a negative value indicates a decrease in pain intensity.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
|
-3.9 mm
Standard Deviation 3.19
|
-4.8 mm
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 ASES Score.
The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as \[(ASES score at week 4) - (ASES score at baseline)\] - a positive value indicates an improvement in shoulder function over time.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
|
39.2 score on a scale
Standard Deviation 25.95
|
12.9 score on a scale
Standard Deviation 22.10
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 ASES Score.
The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as \[(ASES score at week 12) - (ASES score at baseline)\] - a positive value indicates an improvement in shoulder function over time.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=23 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=22 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
|
34.1 score on a scale
Standard Deviation 29.48
|
28.3 score on a scale
Standard Deviation 24.25
|
SECONDARY outcome
Timeframe: Baseline, Week 24The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as \[(ASES score at week 24) - (ASES score at baseline)\] - a positive value indicates an improvement in shoulder function over time
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in American Shoulder and Elbow Surgeons (ASES) Score
|
35.3 score on a scale
Standard Deviation 31.57
|
40.9 score on a scale
Standard Deviation 17.43
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
|
20.7 degrees
Standard Deviation 35.37
|
-4.3 degrees
Standard Deviation 28.93
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
|
32.0 degrees
Standard Deviation 32.17
|
11.7 degrees
Standard Deviation 33.70
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=21 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
|
35.0 degrees
Standard Deviation 30.91
|
23.5 degrees
Standard Deviation 34.11
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
|
26.9 degrees
Standard Deviation 33.34
|
7.5 degrees
Standard Deviation 46.63
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
|
22.7 degrees
Standard Deviation 36.69
|
32.1 degrees
Standard Deviation 35.74
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=21 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
|
31.2 degrees
Standard Deviation 35.43
|
42.8 degrees
Standard Deviation 31.00
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
|
33.9 degrees
Standard Deviation 40.62
|
20.0 degrees
Standard Deviation 43.52
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
|
42.7 degrees
Standard Deviation 29.99
|
34.1 degrees
Standard Deviation 42.23
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=21 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
|
50.5 degrees
Standard Deviation 28.88
|
57.6 degrees
Standard Deviation 48.36
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
|
36.8 degrees
Standard Deviation 46.23
|
15.4 degrees
Standard Deviation 41.96
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
|
55.7 degrees
Standard Deviation 35.47
|
45.0 degrees
Standard Deviation 42.21
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=21 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
|
63.8 degrees
Standard Deviation 37.52
|
66.4 degrees
Standard Deviation 31.67
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
|
28.4 degrees
Standard Deviation 29.09
|
6.0 degrees
Standard Deviation 24.07
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
|
32.3 degrees
Standard Deviation 22.40
|
23.5 degrees
Standard Deviation 28.34
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=21 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
|
36.0 degrees
Standard Deviation 23.43
|
34.3 degrees
Standard Deviation 20.33
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Data was collected and analyzed for participants who completed both baseline and week 4 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
|
-4.2 degrees
Standard Deviation 24.51
|
10.2 degrees
Standard Deviation 24.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data was collected and analyzed for participants who completed both baseline and week 12 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=22 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=23 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
|
-1.0 degrees
Standard Deviation 15.53
|
13.1 degrees
Standard Deviation 27.41
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data was collected and analyzed for participants who completed both baseline and week 24 visit.
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Outcome measures
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=20 Participants
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=21 Participants
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
|
0.9 degrees
Standard Deviation 14.93
|
14.1 degrees
Standard Deviation 27.04
|
Adverse Events
Intra-articular Injection of Corticosteroid Plus Lidocaine
Intra-articular Injection of ActiveMatrix Plus Lidocaine
Serious adverse events
| Measure |
Intra-articular Injection of Corticosteroid Plus Lidocaine
n=27 participants at risk
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Corticosteroid: Triamcinolone 20 mg (1cc)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
Intra-articular Injection of ActiveMatrix Plus Lidocaine
n=25 participants at risk
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
ActiveMatrix: 1cc ActiveMatrix (Skye Biologics, Inc.)
Lidocaine: Lidocaine 10 mg/mL (5cc)
|
|---|---|---|
|
Cardiac disorders
Heart attack
|
3.7%
1/27 • 6 months
|
0.00%
0/25 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Eric F Berkman, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place