Post-Market Evaluation of the Rotation Medical Rotator Cuff System
- Conditions
- Full Thickness Supraspinatus Tendon TearPartial Thickness Supraspinatus Tendon Tear
- Interventions
- Device: Bioinductive implantDevice: Surgical repair
- Registration Number
- NCT02200939
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full Thickness Tear Bioinductive implant Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Full Thickness Tear Surgical repair Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Partial-Thickness Tear Bioinductive implant Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
- Primary Outcome Measures
Name Time Method Change in Tendon Thickness 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).
Integration of Induced Tissue With Underlying Tendon 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 deltoid?
3. Was there evidence of bursitis in the shoulder?
4. Does the new tissue resemble normal tendon tissue?
5. Does the underlying tendon resemble normal tendon tissue?
6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?Fill-In of Partial Thickness Tears and Underlying Tendon Quality 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%Number of Participants With a Re-Tear 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.
- Secondary Outcome Measures
Name Time Method Procedure Parameters: Device Implant Time Intraoperative 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 Parameters: Procedure Technical Success Intraoperative 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).
American Shoulder and Elbow Society (ASES) Score 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).Constant-Murley Shoulder (CMS) Score 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).
Recovery: Sling Time Post-operatively to study completion, approximately 2 years Cumulative number of days index shoulder was in a sling.
Recovery: Rehabilitation Time Post-operatively to study completion, approximately 2 years Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.
Recovery: Return to Work Post-operatively to study completion, approximately 2 years Cumulative number of days between discharge and return to work (employed subjects only).
Recovery: Return to Normal Daily Activities 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.
Participant Satisfaction 3 months, 1 year, and 2 years Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:
* Strongly Disagree
* Disagree
* Neither Agree or Disagree
* Agree
* Strongly Agree
"Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.
Trial Locations
- Locations (15)
Holy Cross Hospital Orthopedic Research Institute
🇺🇸Fort Lauderdale, Florida, United States
Princeton Orthopaedic Associates, P.A.
🇺🇸Princeton, New Jersey, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Bone & Joint Clinic of Houston
🇺🇸Houston, Texas, United States
Southern California Orthopedic Institute
🇺🇸Van Nuys, California, United States
Twin Cities Orthopedics
🇺🇸Edina, Minnesota, United States
OrthoCarolina Research Institute
🇺🇸Charlotte, North Carolina, United States
Great Lakes Orthopaedic Center
🇺🇸Traverse City, Michigan, United States
ProOrtho Orthopedic Clinic
🇺🇸Kirkland, Washington, United States
Texas Orthopedic Specialists, P.L.L.C.
🇺🇸Bedford, Texas, United States
OrthoIllinois, LTD
🇺🇸Rockford, Illinois, United States
Steadman Hawkins Clinic-Denver
🇺🇸Denver, Colorado, United States
Harbin Clinic Orthopaedics & Sports Medicine Rome
🇺🇸Rome, Georgia, United States
Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr
🇺🇸Towson, Maryland, United States
University of Iowa Sports Medicine
🇺🇸Iowa City, Iowa, United States