Bioinductive Patch for Rotator Cuff Tears

Overseen by Stephanie J Muh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Henry Ford Health System

Disqualifiers: Prior shoulder surgery, Cancer, Autoimmune disorders, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial compares standard rotator cuff surgery with and without a special patch that helps the tendon heal. It targets patients who haven't improved with other treatments. The patch is expected to improve healing by encouraging tendon regrowth.

Do I need to stop 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 data supports the effectiveness of the treatment Regeneten Bioinductive Implant for rotator cuff tears?

Research shows that the Regeneten Bioinductive Implant can increase tendon thickness and improve healing in rotator cuff repairs, potentially reducing the chance of the tear happening again. Studies have also shown promising early results in creating a healing response and thickening the injured tendon. ^{1 2 3 4 5}

Is the Bioinductive Patch for Rotator Cuff Tears safe for humans?

The Bioinductive Patch, also known as the Regeneten Bioinductive Implant, has been used in surgeries to help heal rotator cuff tears. Studies have shown it can increase tendon thickness and support healing, but some patients may experience increased stiffness or need additional surgery. Overall, it is considered safe, but like any medical procedure, there are potential risks. ^{1 4 5 6 7}

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

The Regeneten Bioinductive Implant is unique because it uses a bioinductive patch made from bovine collagen to promote healing and increase tendon thickness, unlike traditional repairs that focus solely on mechanical fixation. This patch helps improve the biology at the repair site by enhancing collagen formation and reducing strain on the tendon, which may lead to better healing outcomes. ^{4 5 7 8 9}

Research Team

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health

Eligibility Criteria

This trial is for adults over 18 who have medium to massive full-thickness rotator cuff tears, confirmed by imaging, and haven't improved after at least 6 weeks of physical therapy. It's not for those with previous shoulder surgeries (other than diagnostic arthroscopy), active infections, planned open shoulder repairs, acute injuries, small or partial tears, subscapularis tendon involvement, or autoimmune conditions.

Inclusion Criteria

I am scheduled for a shoulder surgery to repair the rotator cuff.

Ability to read and understand English.

I am 18 years old or older.

Exclusion Criteria

I have had surgery on my shoulder before, but only for diagnosis.

I have a partial tear in my shoulder's rotator cuff.

I have a small tear in my shoulder tendon.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo arthroscopic rotator cuff repair, with the study group receiving an additional bioinductive patch implant

Surgical procedure

Follow-up

Participants are monitored for rotator cuff repair integrity and other outcomes using ultrasound and PROMs scores

1 year

Ultrasound at 1 year, regular follow-up visits

Long-term follow-up

Participants are monitored for additional outcomes such as shoulder strength, range of motion, and complications

2 years

Treatment Details

Interventions

• Regeneten Bioinductive Implant (Bioinductive Patch)

Trial Overview The study compares two ways to fix a torn rotator cuff in the shoulder: standard arthroscopic repair versus the same procedure plus a Bioinductive Implant. The main goal is to see if the implant helps maintain the repair after one year using ultrasound checks.

Participant Groups

Group I: Study Group Experimental Treatment 3 Interventions

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Group II: Control Group Active Control 2 Interventions

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

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

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]

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 of 16 patients with posterosuperior rotator cuff tears, the use of bioabsorbable poly-4-hydroxybutyrate patches during arthroscopic repair resulted in a low retear rate of 6.7% and good tendon integrity after one year, as confirmed by MRI.

Patients showed significant improvements in shoulder function, with the Constant-Murley score increasing from 44 to 89 points, indicating effective clinical outcomes and high patient satisfaction following the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic repair of posterosuperior rotator cuff tears with bioabsorbable patch augmentation: a magnetic resonance-controlled case series with 1-year follow-up. Burkhard, MD., Dietrich, M., Andronic, O., 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]

The bioinductive collagen implant used for treating partial- and full-thickness rotator cuff tears demonstrated significant safety and efficacy, with patients showing marked improvements in pain and function at 1-year follow-up, as measured by various standardized outcomes.

In the study involving patients with rotator cuff tears, 84% of those with partial tears and 72% of those with full-thickness tears reported clinically meaningful improvements in pain and shoulder function, indicating the implant's effectiveness in promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. McIntyre, LF., Bishai, SK., Brown, PB., et al.[2020]

Partial-thickness and full-thickness rotator cuff tears are challenging to treat, with high retear rates and over 50% of partial tears progressing, indicating a need for improved treatment strategies.

The use of a bovine bioinductive patch in an all-arthroscopic technique may enhance healing and reduce strain on surrounding tissues, offering a promising option for surgeons dealing with these types of rotator cuff injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Augmentation: Surgical Technique Using Bovine Collagen Bioinductive Implant. Washburn, R., Anderson, TM., Tokish, JM.[2020]

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]

A new bio-inductive patch made from type I bovine collagen has shown promising healing rates of 89% to 96% in rotator cuff repairs, suggesting it can enhance recovery by improving collagen formation at the repair site.

The patch has been safely used in various tear sizes and types without any reported adverse reactions, although it significantly increases the cost of the procedure and lacks data from randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotator Cuff Repair: Patch the Shoulder. Thon, S., Savoie, FH.[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. 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]

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

Arthroscopic repair of posterosuperior rotator cuff tears with bioabsorbable patch augmentation: a magnetic resonance-controlled case series with 1-year follow-up. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. 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]

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

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. [2020]

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

Arthroscopic Rotator Cuff Augmentation: Surgical Technique Using Bovine Collagen Bioinductive Implant. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Rotator Cuff Repair: Patch the Shoulder. [2020]