REGENETEN™ Bioinductive Implant System in Full-thickness Tears

(REGENETEN Trial)

Recruiting at 29 trial locations

Overseen By Salomé Nel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Must not be taking: Steroids

Disqualifiers: Osteoarthritis, Infections, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: Intra-operative time

119 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a shoulder tendon repair surgery with an extra treatment called REGENETEN. It targets patients with large or massive shoulder tears. REGENETEN helps by providing a structure for new tissue to grow, aiding the healing process. REGENETEN is a bioinductive type-1 collagen implant used to repair partial-thickness rotator cuff tears without formal tendon-bone reattachment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have used oral or injected steroids in the last 4 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment Arthroscopic rotator cuff repair with the REGENETEN™ Bioinductive Implant System?

Research shows that using the REGENETEN bio-inductive collagen implant in rotator cuff repair can increase tendon thickness and improve healing rates, reducing the chances of the tear happening again. Studies also indicate that this implant can enhance clinical outcomes for patients with full-thickness rotator cuff tears. ^{1 2 3 4 5}

Is the REGENETEN Bioinductive Implant safe for humans?

The REGENETEN Bioinductive Implant, used in rotator cuff repair, has been shown to be safe in humans, with studies indicating it can be used effectively to promote healing in rotator cuff tears. ^{1 2 3 4 6}

How is the REGENETEN Bioinductive Implant treatment different from other treatments for rotator cuff repair?

The REGENETEN Bioinductive Implant is unique because it uses a bio-inductive collagen implant to promote new tissue growth and increase tendon thickness, which can help improve healing in rotator cuff repairs. Unlike other treatments that may provide immediate structural support, this implant focuses on enhancing the body's natural healing process over time. ^{2 3 5 7 8}

Research Team

Chris Peach, MBBS MD FRCS (Tr&Orth)

Principal Investigator

Manchester University NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

You need to have surgery to repair a rotator cuff tear using arthroscopy.

Subject is > 40 years of age (no upper limit);

Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;

Exclusion Criteria

You have a current or previous shoulder infection on the same side as the study treatment.

You are allergic to substances that come from cows.

You have a tear in your shoulder muscle that cannot be fully repaired.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Arthroscopic rotator cuff repair (ARCR) with or without REGENETEN™ Bioinductive Implant

Intra-operative time

Initial Follow-up

Participants are monitored post-surgery at 2 weeks and 6 weeks for initial recovery and assessment

6 weeks

2 visits (in-person)

Extended Follow-up

Participants are monitored for safety and effectiveness at 3, 6, 12, and 24 months post-surgery

24 months

4 visits (in-person)

Treatment Details

Interventions

• Arthroscopic rotator cuff repair
• Arthroscopic rotator cuff repair for revision surgery
• REGENETEN™ Bioinductive Implant System

Participant Groups

Group I: ARCR revision group Experimental Treatment 1 Intervention

ARCR revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN

Group II: ARCR augmented with REGENETEN™ Bioinductive Implant Experimental Treatment 1 Intervention

During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.

Group III: ARCR alone Placebo Group 1 Intervention

The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead 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

Findings from Research

In a study of 22 patients with massive rotator cuff tears, only 41% achieved substantial clinical benefit from biologically enhanced patch augmentation repair, indicating that while some patients improved, many did not experience significant recovery.

The procedure showed a significant increase in shoulder function as measured by the Simple Shoulder Test, but pain score improvements were not statistically significant, suggesting that while the technique may enhance function, it may not effectively reduce pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears. Muench, LN., Kia, C., Jerliu, A., et al.[2020]

The recurrence of rotator cuff tears after arthroscopic repair is often due to failure of tendon healing, which can be linked to poor tissue quality.

The use of a resorbable bio-inductive collagen implant (REGENETEN) has been shown to enhance tendon thickness during rotator cuff repair, potentially improving healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant. Pupa, L., Sheth, M., Goldenberg, N., et al.[2022]

In a study of 115 patients with full-thickness rotator cuff tears, the use of a bioinductive bovine collagen implant during repair resulted in a low retear rate of 16.5% at one year, which is favorable compared to existing literature.

Patients showed significant improvement in shoulder function, with 91.7% meeting the minimally clinically important difference in the American Shoulder and Elbow Surgeons (ASES) score at one year, indicating that the collagen implant may enhance recovery outcomes after rotator cuff repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study. Bushnell, BD., Connor, PM., Harris, HW., et al.[2022]

In a study involving 210 patients undergoing arthroscopic repair of full-thickness rotator cuff tears, the use of a resorbable bioinductive bovine collagen implant led to significant improvements in shoulder function and quality of life measures after one year, regardless of the size of the tear.

The study reported a 10.4% rate of serious complications, including revision surgeries and other issues, indicating that while the implant is effective, there are risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. McIntyre, LF., McMillan, S., Trenhaile, SW., et al.[2022]

The BioBrace™ is a novel bio-inductive scaffold designed for rotator cuff augmentation, combining the benefits of tissue induction and structural strength, which addresses the limitations of existing treatments.

This innovative implant uses a unique composition of type I collagen and bio-resorbable microfilaments, aiming to enhance tissue incorporation while providing immediate support during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. Cheesman, QT., Szukics, PF., Stark, M., et al.[2022]

In cases of failed rotator cuff repairs, particularly medial failures, using patch augmentation with an absorbable synthetic scaffold can improve the healing environment and reinforce weak areas of the cuff.

The study outlines a detailed revision technique that enhances the mechanical stability of the rotator cuff, potentially leading to better outcomes in patients with compromised healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Revision of Medial Rotator Cuff Failure Augmented With a Bioabsorbable Patch. Buess, E., Hackl, M., Buxbaumer, P.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Patch Augmentation in Rotator Cuff Repair. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Revision of Medial Rotator Cuff Failure Augmented With a Bioabsorbable Patch. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic revision of failed rotator cuff repairs: technique and results. [2022]