Bioinductive Patch for Rotator Cuff Tears

Overseen By Stephanie J Muh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Henry Ford Health System

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

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special patch called the Regeneten Bioinductive Implant to determine its effectiveness in healing rotator cuff tears. Researchers compare two groups: one receives standard shoulder surgery, while the other receives the same surgery plus the patch. They assess whether the patch group experiences better healing after a year. Individuals with medium to massive rotator cuff tears in specific shoulder tendons, who have not improved with physical therapy, might be suitable candidates. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients, offering participants a chance to contribute to medical knowledge while potentially enhancing their own healing process.

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 is the safety track record for the Regeneten Bioinductive Implant?

Research has shown that the Regeneten Bioinductive Implant is generally safe for repairing rotator cuff injuries. Studies indicate that this collagen patch aids in healing, with many patients experiencing improvements. Notably, the implant reduces the risk of the rotator cuff tearing again by 65%. This suggests it is well-tolerated and effective. Therefore, those considering joining a trial for this implant can feel reassured about its safety based on previous research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Regeneten Bioinductive Implant is unique because it introduces a bio-inductive patch that aids in tendon healing, which is not part of the standard surgical treatments like simple arthroscopic rotator cuff repair. Unlike conventional methods that rely solely on surgical repair, this implant promotes the body's natural healing processes by inducing new tissue growth over the rotator cuff. Researchers are excited about this treatment because it potentially enhances tendon repair durability and accelerates recovery, offering hope for improved outcomes in rotator cuff tear treatments.

What evidence suggests that the Regeneten Bioinductive Implant might be an effective treatment for rotator cuff tears?

Research has shown that the Regeneten Bioinductive Implant, which participants in this trial may receive, helps heal rotator cuff injuries more effectively. One study found it reduced the risk of re-injury by 68%, a significant improvement. Another study reported that individuals with the implant experienced better shoulder movement and less pain. The implant encourages new tissue growth, strengthening the repaired area. Overall, these findings suggest that the implant can greatly enhance the success of rotator cuff repairs. ^{2 3 5 6 7}

Who Is on the Research Team?

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

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 have tried physical therapy for over 6 weeks without improvement.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Regeneten Bioinductive Implant

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.

How Is the Trial Designed?

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.

Regeneten Bioinductive Implant is already approved in United States for the following indications:

Approved in United States as REGENETEN Bioinductive Implant for:

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

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

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

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

The Clinical Efficacy of the Regeneten Bioinductive Implant ... This study systematically reviews the evidence on the effectiveness of the Regeneten Bioinductive Implant in improving healing outcomes.

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 ... The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement ...

4. smith-nephew.com smith-nephew.com/en/blogs/2025/03/18/new-study-on-regeneten-bioinductive-implant

New study on REGENETEN◊ Bioinductive Implant New study confirms Smith+Nephew's REGENETEN◊ Bioinductive Implant reduces full-thickness rotator cuff re-tear rates¹ by 68%.

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. 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.

7. smith-nephew.com smith-nephew.com/en/news/2025/09/11/20250911-sn-unveils-major-clinical-evidence-and-patient-access-updates

Smith+Nephew unveils major clinical evidence and patient ... Miguel A. Ruiz Ibán and colleagues demonstrated a sustained 65% relative reduction in re-tear rates when using the REGENETEN Bioinductive ...