Status:
COMPLETED
Post-Market Evaluation of the Rotation Medical Rotator Cuff System
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Partial Thickness Supraspinatus Tendon Tear
Full Thickness Supraspinatus Tendon Tear
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2020
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT02200939
Start Date
August 20 2014
End Date
November 24 2020
Last Update
March 2 2022
Active Locations (15)
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1
Southern California Orthopedic Institute
Van Nuys, California, United States, 91405
2
Steadman Hawkins Clinic-Denver
Denver, Colorado, United States, 80111
3
Holy Cross Hospital Orthopedic Research Institute
Fort Lauderdale, Florida, United States, 33334
4
Harbin Clinic Orthopaedics & Sports Medicine Rome
Rome, Georgia, United States, 30165