N/A
N=148
Post-Market Evaluation of the Rotation Medical Rotator Cuff System
Partial Thickness Supraspinatus Tendon Tear · Full Thickness Supraspinatus Tendon Tear
Bottom Line
View on ClinicalTrials.gov: NCT02200939 ↗Enrolled (actual)
148
Serious AEs
8.8%
Results posted
Mar 2022
Primary outcome: Primary: Change in Tendon Thickness — 1.7; 2.6; 1.2; 1.2 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bioinductive implant (Device); Surgical repair (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tendon Thickness |
1.7; 2.6; 1.2; 1.2; 1.4; 2.3 | — |
| PRIMARY Integration of Induced Tissue With Underlying Tendon |
2; 0; 8; 2; 7; 18 | — |
| PRIMARY Fill-In of Partial Thickness Tears and Underlying Tendon Quality |
1; 0; 0; 2; 1; 3 | — |
| PRIMARY Number of Participants With a Re-Tear |
0; 1; 3; 10; 0; 1 | — |
| SECONDARY Procedure Parameters: Device Implant Time |
28.00; 10.50 | — |
| SECONDARY Procedure Parameters: Procedure Technical Success |
33; 115; 0; 0 | — |
| SECONDARY American Shoulder and Elbow Society (ASES) Score |
4.6; 4; 4.8; 5.2; 1.8; 1.3 | — |
| SECONDARY Constant-Murley Shoulder (CMS) Score |
51.6; 58.9; 51.2; 48.5; 51.5; 73.7 | — |
| SECONDARY Recovery: Sling Time |
19.90; 26.60; 44.60; 39.20 | — |
| SECONDARY Recovery: Rehabilitation Time |
14.30; 21.20; 22.50; 21.80 | — |
| SECONDARY Recovery: Return to Work |
46.00; 58.80; 50.00; 66.50 | — |
| SECONDARY Recovery: Return to Normal Daily Activities |
102.40; 147.30; 130.50; 130.90 | — |
| SECONDARY Participant Satisfaction |
0; 0; 0; 1; 0; 0 | — |
Summary
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.
Eligibility Criteria
INCLUSION CRITERIA
Subjects enrolled in the study MUST meet all of the following criteria:
- At least 21 years of age
- Rotator cuff tear requiring surgery that meets either criterion A or B:
A. Medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair
- Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
- MRI of the shoulder within 60 days prior to the study procedure
- Willing to comply with the prescribed post-operative rehabilitation program
- Willing to be available for each protocol-required follow-up examination
- Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
- Ability to read, understand, and complete subject-reported outcomes in English
EXCLUSION CRITERIA
Subjects enrolled in the study MUST NOT meet any of the following criteria:
- Massive rotator cuff tears (≥ 5 cm)
- Acute rotator cuff tears less than 12 months from injury
- Previous rotator cuff surgery on the index shoulder
- Instability of the index shoulder
- Chondromalacia of index shoulder ≥ Grade 3
- Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2
- Calcification of the index shoulder rotator cuff
- Genetic collagen disease
- History of insulin dependent diabetes
- History of auto-immune or immunodeficiency disorders
- History of chronic inflammatory disorders
- Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
- History of heavy smoking (> 1 pack per day) within last 6 months
- Hypersensitivity to bovine-derived materials
- Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
- Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder
- Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
- History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
- History of cognitive or mental health status that interferes with study participation
Data sourced from ClinicalTrials.gov (NCT02200939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.