Regeneten Augmentation for Shoulder Surgery Healing
AP
SO
MK
Overseen ByMichael Keller
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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
GC
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
I am healthy enough for shoulder replacement surgery.
I am 50 years old or older.
I am undergoing treatment involving surgery on my shoulder tendon.
See 3 more
Exclusion Criteria
Object to using cow derived material
I had surgery on my shoulder that involved treatment to the subscapularis.
I have had a reverse shoulder replacement.
See 3 more
Treatment Details
Interventions
- Regeneten
- Standard repair
Trial OverviewThe RESTOR study is testing whether adding a Regeneten implant to standard repair after total shoulder arthroplasty can better heal the subscapularis tendon and improve patient outcomes. Participants will receive either just the standard repair or the standard repair with Regeneten augmentation.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard repairExperimental Treatment1 Intervention
Standard subscapularis repair
Group II: RegenetenActive Control1 Intervention
Standard subscapularis repair with Regeneten augmentation group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Trials
891
Recruited
2,659,000+
Smith & Nephew, Inc.
Industry Sponsor
Trials
176
Recruited
23,500+
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
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