21 and older, any sex, with Partial Thickness Supraspinatus Tendon Tear or Full Thickness Supraspinatus Tendon Tear. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Tendon ThicknessPrimary· Pre-operatively (baseline) to 3 month, 1 year, and 2 year
The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).
Change from Baseline to 3 Month
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1.7
± 1.5
High Partial-Thickness Tear
2.6
± 19
Medium Full Thickness Tear
1.2
± 1.7
Large Full Thickness Tear
1.2
± 2.2
Change from Baseline to 1 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1.4
± 1.3
High Partial-Thickness Tear
2.3
± 1.8
Medium Full Thickness Tear
0.6
± 1.9
Large Full Thickness Tear
0.7
± 2.2
Change from Baseline to 2 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1.2
± 1.3
High Partial-Thickness Tear
1.8
± 2.2
Medium Full Thickness Tear
0.7
± 2.0
Large Full Thickness Tear
0.7
± 2.3
Change from 3 Months to 1 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
-0.3
± 0.4
High Partial-Thickness Tear
-0.4
± 0.6
Medium Full Thickness Tear
-0.5
± 1.3
Large Full Thickness Tear
-0.4
± 1.9
Change from 3 Months to 2 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
-0.3
± 0.4
High Partial-Thickness Tear
-0.8
± 1.2
Medium Full Thickness Tear
-0.6
± 1.6
Large Full Thickness Tear
-0.6
± 1.8
Change from 1 Year to 2 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
-0.1
± 0.3
High Partial-Thickness Tear
-0.4
± 0.9
Medium Full Thickness Tear
-0.2
± 0.9
Large Full Thickness Tear
-0.1
± 1.1
Integration of Induced Tissue With Underlying TendonPrimary· 3 months, 1 year, and 2 years
Partial-thickness tears were classified as Intermediate (3-6 mm) or High (\> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:
1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the delto
3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
2
High Partial-Thickness Tear
0
Medium Full Thickness Tear
8
Large Full Thickness Tear
2
Intermediate Partial-Thickness Tear
7
High Partial-Thickness Tear
18
Medium Full Thickness Tear
14
Large Full Thickness Tear
7
Intermediate Partial-Thickness Tear
3
High Partial-Thickness Tear
3
Medium Full Thickness Tear
43
Large Full Thickness Tear
38
1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
5
High Partial-Thickness Tear
11
Medium Full Thickness Tear
5
Large Full Thickness Tear
5
Intermediate Partial-Thickness Tear
7
High Partial-Thickness Tear
9
Medium Full Thickness Tear
60
Large Full Thickness Tear
43
2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
2
High Partial-Thickness Tear
7
Medium Full Thickness Tear
2
Large Full Thickness Tear
2
Intermediate Partial-Thickness Tear
9
High Partial-Thickness Tear
13
Medium Full Thickness Tear
60
Large Full Thickness Tear
38
3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
8
High Partial-Thickness Tear
12
Medium Full Thickness Tear
39
Large Full Thickness Tear
24
Intermediate Partial-Thickness Tear
1
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
3
High Partial-Thickness Tear
9
Medium Full Thickness Tear
26
Large Full Thickness Tear
23
1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
4
High Partial-Thickness Tear
6
Medium Full Thickness Tear
8
Large Full Thickness Tear
10
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
8
High Partial-Thickness Tear
15
Medium Full Thickness Tear
57
Large Full Thickness Tear
38
2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1
High Partial-Thickness Tear
4
Medium Full Thickness Tear
11
Large Full Thickness Tear
8
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
10
High Partial-Thickness Tear
16
Medium Full Thickness Tear
51
Large Full Thickness Tear
32
3 Month: Was there evidence of bursitis in the shoulder?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
12
High Partial-Thickness Tear
21
Medium Full Thickness Tear
65
Large Full Thickness Tear
48
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
1 Year: Was there evidence of bursitis in the shoulder?
Group
Value
95% CI
Intermediate Partial-Thickness Tear
12
High Partial-Thickness Tear
21
Medium Full Thickness Tear
66
Large Full Thickness Tear
48
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
0
Medium Full Thickness Tear
0
Large Full Thickness Tear
0
Fill-In of Partial Thickness Tears and Underlying Tendon QualityPrimary· 3 months, 1 year, and 2 years
For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:
* 0 to \<25%
* 25% to \<50%
* 50% to \< 75%
* 75% to \< 100%
* 100%
3 Months
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1
High Partial-Thickness Tear
0
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
2
Intermediate Partial-Thickness Tear
1
High Partial-Thickness Tear
3
Intermediate Partial-Thickness Tear
8
High Partial-Thickness Tear
11
1 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
1
Intermediate Partial-Thickness Tear
1
High Partial-Thickness Tear
0
Intermediate Partial-Thickness Tear
2
High Partial-Thickness Tear
3
Intermediate Partial-Thickness Tear
7
High Partial-Thickness Tear
10
2 Years
Group
Value
95% CI
Intermediate Partial-Thickness Tear
0
High Partial-Thickness Tear
1
Intermediate Partial-Thickness Tear
1
High Partial-Thickness Tear
2
Intermediate Partial-Thickness Tear
2
High Partial-Thickness Tear
2
Intermediate Partial-Thickness Tear
8
High Partial-Thickness Tear
11
Number of Participants With a Re-TearPrimary· 3 months, 1 year, and 2 years
Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.
Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.
Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).
Group
Value
95% CI
Partial-Thickness Tear
33
Full Thickness Tear
115
Partial-Thickness Tear
0
Full Thickness Tear
0
American Shoulder and Elbow Society (ASES) ScoreSecondary· Baseline, 3 month, 1 year, and 2 years
The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:
1. ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).
2. ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).
3. ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).
Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).
Baseline: ASES Pain Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
4.6
± 1.9
High Partial-Thickness Tear
4
± 2.7
Medium Full Thickness Tear
4.8
± 2.3
Large Full Thickness Tear
5.2
± 2.6
3 Month: ASES Pain Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1.8
± 1.9
High Partial-Thickness Tear
1.3
± 1.6
Medium Full Thickness Tear
1.8
± 2.2
Large Full Thickness Tear
1.7
± 2
1 Year: ASES Pain Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
1.2
± 1.6
High Partial-Thickness Tear
0.2
± 0.5
Medium Full Thickness Tear
0.5
± 1.2
Large Full Thickness Tear
0.5
± 1.4
2 Years: ASES Pain Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
0.2
± 0.4
High Partial-Thickness Tear
0.3
± 0.7
Medium Full Thickness Tear
0.2
± 0.8
Large Full Thickness Tear
0.5
± 1.2
Baseline: Shoulder Function Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
15.3
± 5.4
High Partial-Thickness Tear
18
± 8.5
Medium Full Thickness Tear
15.9
± 5.7
Large Full Thickness Tear
14.2
± 6.4
3 Month: Shoulder Function Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
17
± 7
High Partial-Thickness Tear
21.1
± 8
Medium Full Thickness Tear
14.6
± 6.7
Large Full Thickness Tear
15.6
± 7.2
1 Year: Shoulder Function Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
27
± 4
High Partial-Thickness Tear
26.8
± 6.8
Medium Full Thickness Tear
27.8
± 4.2
Large Full Thickness Tear
27.4
± 5.8
2 Years: Shoulder Function Score
Group
Value
95% CI
Intermediate Partial-Thickness Tear
27.7
± 3.4
High Partial-Thickness Tear
26.6
± 9.1
Medium Full Thickness Tear
27.9
± 6.6
Large Full Thickness Tear
29.2
± 1.9
Constant-Murley Shoulder (CMS) ScoreSecondary· Baseline, 3 months, 1 year, and 2 years
The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).
Baseline
Group
Value
95% CI
Intermediate Partial-Thickness Tear
51.6
± 5.6
High Partial-Thickness Tear
58.9
± 19.6
Medium Full Thickness Tear
51.2
± 16.8
Large Full Thickness Tear
48.5
± 18.1
3 Months
Group
Value
95% CI
Intermediate Partial-Thickness Tear
51.5
± 13.8
High Partial-Thickness Tear
73.7
± 15.2
Medium Full Thickness Tear
63.2
± 16.8
Large Full Thickness Tear
65.2
± 14.7
1 Year
Group
Value
95% CI
Intermediate Partial-Thickness Tear
82.2
± 10.4
High Partial-Thickness Tear
85.6
± 11.3
Medium Full Thickness Tear
79.1
± 11.8
Large Full Thickness Tear
85.3
± 9.6
2 Years
Group
Value
95% CI
Intermediate Partial-Thickness Tear
83.3
± 9.9
High Partial-Thickness Tear
93.8
± 6
Medium Full Thickness Tear
83.7
± 9.5
Large Full Thickness Tear
84.4
± 9.5
Recovery: Sling TimeSecondary· Post-operatively to study completion, approximately 2 years
Cumulative number of days index shoulder was in a sling.
Group
Value
95% CI
Intermediate Partial-Thickness Tear
19.90
± 9.39
High Partial-Thickness Tear
26.60
± 15.94
Medium Full Thickness Tear
44.60
± 43.23
Large Full Thickness Tear
39.20
± 20.70
Recovery: Rehabilitation TimeSecondary· Post-operatively to study completion, approximately 2 years
Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.
Group
Value
95% CI
Intermediate Partial-Thickness Tear
14.30
± 7.19
High Partial-Thickness Tear
21.20
± 11.08
Medium Full Thickness Tear
22.50
± 11.01
Large Full Thickness Tear
21.80
± 14.44
Recovery: Return to WorkSecondary· Post-operatively to study completion, approximately 2 years
Cumulative number of days between discharge and return to work (employed subjects only).
Group
Value
95% CI
Intermediate Partial-Thickness Tear
46.00
± 62.99
High Partial-Thickness Tear
58.80
± 108.70
Medium Full Thickness Tear
50.00
± 72.93
Large Full Thickness Tear
66.50
± 83.72
Recovery: Return to Normal Daily ActivitiesSecondary· Post-operatively to study completion, approximately 2 years
Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.
Group
Value
95% CI
Intermediate Partial-Thickness Tear
102.40
± 99.95
High Partial-Thickness Tear
147.30
± 125.30
Medium Full Thickness Tear
130.50
± 64.45
Large Full Thickness Tear
130.90
± 84.42
Adverse events — posted to ClinicalTrials.gov
Time frame: Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Partial-Thickness Tear
Serious: 1/33 (3%)
Deaths: 0/33
Full Thickness Tear
Serious: 12/115 (10%)
Deaths: 0/115
Serious adverse events (9 terms)
Reaction
System
Partial-Thickness Tear
Full Thickness Tear
Index shoulder recurrent rotator cuff tear
Musculoskeletal and connective tissue disorders
—
—
Cardiac Ablation
Cardiac disorders
—
—
Index shoulder new rotator cuff tear and lack of healing
The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT02784600 — Rotation Medical Bioinductive Implant Database Registry
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Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 2 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02200939.