REGENETEN Implant for Rotator Cuff Injury

(REGENETEN Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implant, the REGENETEN™ Bioinductive Implant System, to determine if it repairs full-thickness rotator cuff tears more effectively than standard surgery. The study compares three groups: one using the implant with surgery, one with surgery alone (arthroscopic rotator cuff repair), and one for individuals needing a second surgery after a previous repair (arthroscopic rotator cuff repair for revision surgery). Individuals with a painful rotator cuff tear at least 3 cm wide who require surgery might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for rotator cuff tears.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the REGENETEN Bioinductive Implant System is generally safe for repairing rotator cuff injuries. One study found that this implant resulted in a low retear rate of about 11% in patients with medium to large tears after one year, indicating that the body well-accepts the implant.

Other studies have demonstrated that the bioinductive collagen patch used in the implant is a safe addition to rotator cuff repair. Patients experienced significant improvement in their condition after using the patch, suggesting that the implant aids in healing and is unlikely to cause serious side effects.

Overall, the REGENETEN Bioinductive Implant System appears to be a safe option for those needing rotator cuff repair or revision surgery. The available evidence supports its safety, making it a promising choice for improving recovery outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the REGENETEN™ Bioinductive Implant System for rotator cuff tears because it introduces a new way to enhance tendon healing. Unlike traditional arthroscopic rotator cuff repair (ARCR) that solely relies on stitching the tendon, the REGENETEN™ implant acts as a scaffold, promoting tissue growth and potentially speeding up recovery. By attaching the implant to the tendon and bone with small anchors, it helps regenerate tissue at the site of the tear, which might lead to stronger, more resilient repairs compared to standard procedures. This innovative approach could offer a significant improvement over current treatments that don't incorporate bioinductive technology.

What evidence suggests that this trial's treatments could be effective for rotator cuff tear repair?

Research has shown that the REGENETEN™ Bioinductive Implant System can help repair complete rotator cuff tears. One study found that 966 tears treated with the REGENETEN implant showed significant improvements in patient comfort and tendon thickness. Additionally, the implant had a relatively low retear rate of 16.5% after one year for medium and large tears. In this trial, participants in the "ARCR augmented with REGENETEN™ Bioinductive Implant" arm will receive this implant during minimally invasive rotator cuff surgery. These results suggest that using the REGENETEN implant can improve healing and reduce the chance of re-injury compared to the "ARCR alone" arm, which involves standard repair methods without the implant. ^{1 2 3 6 7}

Who Is on the Research Team?

Chris Peach, MBBS MD FRCS (Tr&Orth)

Principal Investigator

Manchester University NHS Foundation Trust

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

Group I: Revision group Experimental Treatment 1 Intervention

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

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39869884/

The Clinical Efficacy of the Regeneten Bioinductive Implant ... 17 articles were included in this review, encompassing data on 1062 rotator cuff tears, of which 966 were treated with Regeneten. The implant use resulted in ...

2. 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 ...

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

Bioinductive patch as an augmentation for rotator cuff ... Patients are likely to experience significant subjective improvement in patient-reported outcome measures and significant increases in tendon thickness. Retear ...

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

Retear rates and clinical outcomes at 1 year after repair ... In the current analysis, the adjunctive use of this implant and arthroscopic repair led to a 16.5% rate of retear at 1 year in medium and large full-thickness ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06857084

Evaluation Of Outcomes Following Rotator Cuff Repair ... The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of ...

6. 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.

7. aoj.amegroups.org aoj.amegroups.org/article/view/5816/html

Regeneten bio-inductive collagen scaffold for rotator cuff tears A new bio-inductive scaffold implant has been introduced with the aim of improving the biology and tissue quality at the site of rotator cuff repairs.