75 Participants Needed

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 profile image

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath profile image

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley