Regeneten Augmentation for Shoulder Surgery Healing

Overseen By Michael Keller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Revision arthroplasty, Reverse arthroplasty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Surgical procedure

75 Participants Needed

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

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Subjects are assessed pre-operatively to establish baseline measurements

1 week

1 visit (in-person)

Treatment

Participants undergo total shoulder arthroplasty with or without Regeneten augmentation

Surgical procedure

1 visit (in-person)

Post-operative Follow-up

Participants return for post-operative assessments at Week 2, Weeks 6, Month 3, Month 6, and Year 1

12 months

5 visits (in-person)

Long-term Follow-up

Participants are monitored for subscapularis repair integrity and clinical outcomes

12 months

Treatment Details

Interventions

• Regeneten
• Standard repair

Trial Overview The 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

Group I: Standard repair Experimental Treatment 1 Intervention

Standard subscapularis repair

Group II: Regeneten Active Control 1 Intervention

Standard subscapularis repair with Regeneten augmentation group

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