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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Regeneten implant, a bioinductive collagen implant, can enhance healing and recovery during shoulder surgery. The research compares two groups: one receiving standard shoulder repair and the other receiving repair with the Regeneten implant. Eligible participants need shoulder surgery, have an intact rotator cuff, have not undergone certain shoulder surgeries before, and consent to using materials derived from cows. As an unphased trial, this study provides a unique opportunity to contribute to advancements in shoulder surgery recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Regeneten implant is safe for shoulder surgery?

Research has shown that the Regeneten implant, which aids in healing shoulder injuries, is generally safe. Studies have found that this collagen patch is well-tolerated in rotator cuff surgeries. Many recipients of this implant report significant improvement. These studies have not reported any major serious side effects. This is encouraging for those considering participation in a trial with Regeneten, as past research suggests the treatment is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Regeneten augmentation for shoulder surgery healing because it offers a unique approach by enhancing the standard subscapularis repair with a bioinductive implant. Unlike traditional methods that solely rely on sutures and anchors, Regeneten uses a collagen-based scaffold to promote the body's natural tissue growth. This could potentially lead to faster and more robust healing, reducing recovery time and improving outcomes for patients with shoulder injuries.

What evidence suggests that the Regeneten implant is effective for shoulder surgery healing?

Research has shown that the Regeneten bioinductive patch is a promising tool for improving shoulder surgery outcomes. In this trial, some participants will receive the Regeneten patch alongside standard subscapularis repair. Studies have found that this patch, when used in rotator cuff repairs, can safely boost healing and lead to noticeable improvements in patient well-being. Patients who received the Regeneten patch reported feeling better, suggesting it aids in recovery. The patch also appears to lower the risk of rotator cuff re-tear, although questions remain about its cost and overall benefits. Overall, the Regeneten patch offers hope for better healing in shoulder surgeries. ^{1 2 4 5 6}

Who Is on the Research Team?

Gregory Cvetanovich, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38942225/

Bioinductive patch as an augmentation for rotator cuff ... The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274624004488

Bioinductive patch as an augmentation for rotator cuff ... The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement ...

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(23)01018-6/fulltext

Augmentation of a Transosseous-Equivalent Repair in ... Bioinductive collagen implants reduce rotator cuff retear, yet cost-effectiveness and improvement in clinical outcomes are unclear.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04450342

REGENETEN™ Bioinductive Implant System in Full- ... The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7910780/

Retear rates and clinical outcomes at 1 year after repair ... The purpose of this study was to evaluate healing rates and clinical outcomes of full-thickness rotator cuff repairs augmented with a bioinductive bovine ...

6. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/sports-medicine/regeneten-bioinductive-implant

REGENETEN Bioinductive Implant | Smith+Nephew USA Augment rotator cuff repair tendon growth in partial- and full thickness tears with the REGENETEN Implant, an absorbable, porous advanced healing solution.