Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Completed · Not applicable

Conditions studied: Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear

In brief

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.

Key facts

Study ID

NCT02200939

Run by

Smith & Nephew, Inc.

People needed

148

Starts

2014-08-20

Expected to finish

2020-11-24

Last updated by the study team

2022-03-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern California Orthopedic Institute — Van Nuys, California, United States
• Steadman Hawkins Clinic-Denver — Denver, Colorado, United States
• Holy Cross Hospital Orthopedic Research Institute — Fort Lauderdale, Florida, United States
• Harbin Clinic Orthopaedics & Sports Medicine Rome — Rome, Georgia, United States
• OrthoIllinois, LTD — Rockford, Illinois, United States
• University of Iowa Sports Medicine — Iowa City, Iowa, United States
• Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr — Towson, Maryland, United States
• Great Lakes Orthopaedic Center — Traverse City, Michigan, United States
• Twin Cities Orthopedics — Edina, Minnesota, United States
• Princeton Orthopaedic Associates, P.A. — Princeton, New Jersey, United States
• OrthoCarolina Research Institute — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Texas Orthopedic Specialists, P.L.L.C. — Bedford, Texas, United States
• Bone & Joint Clinic of Houston — Houston, Texas, United States
• ProOrtho Orthopedic Clinic — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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