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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment using a collagen graft, known as the Regeneten Bioinductive Implant, can improve recovery for individuals with large rotator cuff tears in the shoulder. The trial compares two treatments: one group receives the standard surgical repair with tissue removal (debridement), while the other group receives the same surgery plus a collagen graft to bridge tendon gaps. Suitable participants have a large shoulder tear over 3 cm, confirmed by an MRI, and experience significant shoulder issues affecting daily activities. The trial seeks to identify which approach results in better shoulder function and fewer re-tears after one year. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this bioinductive collagen graft is safe for rotator cuff repair?

Research shows that using a bioinductive collagen graft, like the Regeneten implant, is generally safe for fixing rotator cuff tears. Studies have found that this treatment can help tendons heal better and become stronger. Many patients report feeling less pain and having improved shoulder movement after receiving the graft.

The Regeneten implant consists of purified collagen, a protein derived from cows. This collagen aids the damaged tendon by creating a supportive environment for new tissue growth. The implant is absorbable, naturally breaking down in the body over time.

Studies have not identified any major safety concerns with this collagen graft. Most patients tolerate it well, suggesting that the treatment is safe and promising for those with rotator cuff injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard rotator cuff repair, which typically involves just stitching up the tear, the Regeneten treatment incorporates a bioinductive collagen graft. This graft is delivered to the subacromial space and placed over the tendon, promoting natural tissue growth right where it's needed. Researchers are excited because this approach not only supports the repair but also potentially enhances healing by encouraging the body to rebuild stronger tendon tissue. This could mean more effective and quicker recoveries for patients compared to conventional repair methods.

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

Studies have shown that using a special collagen patch, such as the Regeneten, can enhance recovery for rotator cuff tears. In this trial, participants in the Graft-Augmented arm will receive this collagen patch along with the standard rotator cuff repair. Patients with these patches often experience less pain and improved shoulder movement after surgery. Research indicates that this treatment can also reduce the risk of recurrent tears. Some reports suggest that individuals with these patches heal better and have fewer repeat tears compared to those undergoing only traditional surgery, which participants in the Non-augmented arm will receive. Although more studies are needed to confirm these findings, early results appear promising for those with difficult-to-heal rotator cuff injuries. ^{1 4 5 6 7}

Who Is on the Research Team?

Ivan Wong, MD

Principal Investigator

Orthopaedic Surgeon

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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. 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 ...

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. 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.

6. sciencedirect.com sciencedirect.com/science/article/pii/S266663832500091X

Safety of bioinductive bovine collagen implants for ... Bioinductive reconstituted type I bovine collagen implants for augmenting arthroscopic rotator cuff repair (ARCR) may improve the healing rate and thickness ...

7. 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.