Regeneten Augmentation for Shoulder Surgery Healing
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.
Research Team
Gregory Cvetanovich, MD
Principal Investigator
Ohio State University
Eligibility Criteria
This trial is for individuals aged 50 or above who need a shoulder replacement and have an intact rotator cuff, confirmed by preoperative exams and imaging. Candidates should be healthy enough to undergo the surgery but cannot participate if they've had prior shoulder surgeries affecting the subscapularis, require complex procedures like reverse arthroplasty, or object to using cow-derived materials.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Subjects are assessed pre-operatively to establish baseline measurements
Treatment
Participants undergo total shoulder arthroplasty with or without Regeneten augmentation
Post-operative Follow-up
Participants return for post-operative assessments at Week 2, Weeks 6, Month 3, Month 6, and Year 1
Long-term Follow-up
Participants are monitored for subscapularis repair integrity and clinical outcomes
Treatment Details
Interventions
- Regeneten
- Standard repair
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Smith & Nephew, Inc.
Industry Sponsor
Dr. Maria Berkman
Smith & Nephew, Inc.
Chief Medical Officer since 2023
MD from Harvard Medical School
Dr. Deepak Nath
Smith & Nephew, Inc.
Chief Executive Officer since 2022
PhD in Theoretical Mechanics, University of California, Berkeley