Bioinductive Collagen Graft for Rotator Cuff Tears

Overseen By Sara Sparavalo, MASc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ivan Wong

Disqualifiers: Subscapular tear, Osteoarthritis, Diabetes, Cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Surgical procedure

76 Participants Needed

Trial Summary

What is the purpose of this trial?

The rotator cuff is a complex of 4 tendons that aid in stabilizing and moving the shoulder. Rotator cuff tears are common shoulder injuries in adults. While some tears can be managed by physiotherapy, other rotator cuff tears will require surgery. On occasion, when a person has had a large rotator cuff tear for a long period of time, the tear can grow and the tendons retract. This effect makes it very difficult for the tendons to be repaired to their normal spot. The most common surgical technique employed to manage a tear that cannot be repaired is to remove all unhealthy, inflamed scar tissue in a process called debridement. Often there is a bone spur that must be shaved down as well. This can help to reduce the pain in the patient as well as assist the range of motion slightly but will not prevent the tear becoming larger. This will also not prevent a re-tear of the tendons. Recently, surgeons have begun using a variety of materials to help reconstruct torn rotator cuffs. New grafts made of highly purified collagen from bovine tendons has been used to bridge large gaps in the tendons, and repair the tendon back to the bone. This technique has been done many times by skilled shoulder surgeons in Canada, the United States and around the world. Initial reports by surgeons who do this procedure show that the patients have less pain and better range of motion than before the surgery. Shoulder surgeons do not know which is the better treatment for large rotator cuff tears. Both treatments (graft and debridement) can reduce pain and improve movement of the shoulder. The purpose of this study is to help determine whether patients who receive an allograft have better function and fewer re-tear at one year after surgery than those who received a debridement alone.

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment Regeneten for rotator cuff tears?

Research shows that using the Regeneten bioinductive collagen implant in rotator cuff repairs can improve healing rates and increase tendon thickness, which may help reduce the chances of the tear happening again. ^{1 2 3 4 5}

Is the Bioinductive Collagen Graft safe for treating rotator cuff tears?

Research shows that the Bioinductive Collagen Graft, also known as Regeneten, is generally safe for treating rotator cuff tears, with studies indicating it can be used safely in humans for this purpose. ^{1 2 3 5 6}

How is the Regeneten treatment different from other treatments for rotator cuff tears?

The Regeneten treatment is unique because it uses a bio-inductive collagen implant to encourage new tissue growth and increase tendon thickness, which can help improve healing in rotator cuff repairs. This approach is different from traditional methods that may not address the issue of poor tissue quality in the rotator cuff. ^{1 2 3 4 6}

Research Team

Ivan Wong, MD

Principal Investigator

Orthopaedic Surgeon

Eligibility Criteria

Adults over 18 with MRI-confirmed large rotator cuff tears (>3cm) are eligible for this trial. It's not suitable for those with shoulder cancer, arthritis, certain types of tear and osteoarthritis, high WORC scores, uncontrolled diabetes (Hgb A1C >7%), infections, comprehension issues post-surgery, nonvascular surgical sites, poor nutrition (Alb <30 g/L), inability to consent, pregnancy or shoulder paralysis/contracture.

Inclusion Criteria

I have a confirmed large shoulder tear via MRI.

Exclusion Criteria

I have been diagnosed with cancer.

I have a stiff shoulder that can't move properly.

My surgery area is not related to blood vessels, confirmed by MRI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a regular rotator cuff repair with debridement or a graft-augmented repair with a bioinductive collagen implant

Surgical procedure

1 visit (in-person)

Early Recovery

Participants recover from surgery and initial outcomes such as pain and shoulder function are assessed

6-8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for healing, re-tear rates, and overall shoulder function

2 years

Periodic visits (in-person and virtual)

Treatment Details

Interventions

• Regeneten

Trial Overview The study is testing two treatments for massive rotator cuff tears: debridement surgery alone versus the use of a bioinductive graft made from bovine tendons after debridement. The goal is to see which method offers better function and fewer re-tears one year post-surgery.

Participant Groups

Group I: Graft-Augmented Experimental Treatment 1 Intervention

Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. Then, the graft will be delivered to the subacromial space and positioned over the bursal surface of the suprasinatus tendon, ensuring that the lateral edge of the implant will overlap with the head of the humerus. The graft will be fixed with tendon and bone staples.

Group II: Non-augmented Active Control 1 Intervention

Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin.

Regeneten is already approved in United States, Canada for the following indications:

Approved in United States as REGENETEN Bioinductive Implant for:

• Rotator cuff tears
• Partial-thickness rotator cuff tears
• Full-thickness rotator cuff tears

Approved in Canada as REGENETEN Bioinductive Implant for:

• Rotator cuff tears
• Partial-thickness rotator cuff tears
• Full-thickness rotator cuff tears

Who Is Running the Clinical Trial?

Ivan Wong

Lead Sponsor

Trials

2

Recruited

110+

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

Findings from Research

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]

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 64 patients with high-grade partial-thickness rotator cuff tears, those treated with a bioinductive collagen patch experienced significantly higher rates of postoperative stiffness and required more reoperations compared to those who did not receive the patch.

Specifically, 8 out of 32 patients in the patch group developed stiffness within the first 12 weeks, leading to 6 reoperations, while only 1 patient in the control group experienced stiffness, highlighting potential concerns about the use of the bioinductive patch in surgical repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. Yeazell, S., Lutz, A., Bohon, H., et al.[2022]

In a study of 48 patients with large and massive rotator cuff tears, both those who received a bio-inductive collagen implant and those who did not showed significant improvements in shoulder function and pain relief after surgery, indicating that both methods are effective.

Magnetic resonance imaging results showed similar healing rates between the two groups, with 55% of the collagen implant group and 53% of the control group having intact repairs, suggesting that while both approaches improve outcomes, the addition of the collagen implant does not significantly enhance healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Repair of Retracted Large and Massive Rotator Cuff Tears with and without Augmentation with a Bio-Inductive Collagen Implant Reveals Substantial and Comparable Clinical Improvement. Zhang, T., Ajayi, A., Hajjar, M., et al.[2023]

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]

References

1. 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]

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

Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. [2022]

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

Arthroscopic Repair of Retracted Large and Massive Rotator Cuff Tears with and without Augmentation with a Bio-Inductive Collagen Implant Reveals Substantial and Comparable Clinical Improvement. [2023]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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