BioBrace® Implant for Rotator Cuff Tears

(REinForce Trial)

Overseen By Jeffery Grebner, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CONMED Corporation

Must not be taking: Oral steroids, Narcotic pain medication

Disqualifiers: Insulin-dependent diabetes, Active smoker, others

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

Compensation: Varies

Number of Visits: 5

Duration: Surgical procedure

268 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used oral steroids or had a steroid injection within 6 weeks before surgery. If you are on prescription narcotic pain medication, you may not be eligible to participate.

What data supports the effectiveness of the treatment Arthroscopic rotator cuff repair with BioBrace® Implant augmentation?

Research shows that using bio-composite scaffolds like BioBrace® can combine the benefits of promoting new tissue growth and providing structural strength, which may help reduce the chances of the rotator cuff tearing again after surgery. Additionally, studies on similar bioinductive collagen implants have shown improved healing rates and clinical outcomes in rotator cuff repairs. ^{1 2 3 4 5}

Is the BioBrace® Implant generally safe for humans?

The BioBrace® Implant is designed to combine tissue growth and strength, but like other implants, it may carry risks such as tissue reaction or complications from the materials used. No specific safety issues unique to BioBrace® were highlighted, but general risks associated with similar implants include tissue reaction and complications from the materials. ^{1 3 4 6 7}

How does the BioBrace® Implant treatment for rotator cuff tears differ from other treatments?

The BioBrace® Implant is unique because it combines the benefits of providing immediate structural strength and promoting new tissue growth, thanks to its bio-inductive scaffold made of porous collagen and bio-resorbable microfilaments. This dual function addresses the common issues of retear and insufficient tissue healing seen in traditional rotator cuff repair methods. ^{1 2 8 9 10}

Eligibility Criteria

This trial is for men and women aged 40-70 with a full-thickness tear in their shoulder tendons, specifically the supraspinatus or infraspinatus. The tear should be between 2 to 5 cm. Participants must have had chronic shoulder pain for at least three months despite trying painkillers, anti-inflammatory drugs, steroid injections, activity changes, or physical therapy.

Inclusion Criteria

You are engaging in physical therapy or home-guided exercises.

I am not taking NSAIDs regularly.

I have a tear in my shoulder tendon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo arthroscopic rotator cuff repair with or without BioBrace® Implant

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at 6 weeks, 3, 6, and 12 months post-op

Treatment Details

Interventions

• Arthroscopic rotator cuff repair
• Arthroscopic rotator cuff repair with BioBrace® Implant augmentation

Trial Overview The study compares traditional arthroscopic repair of rotator cuff tears against the same procedure enhanced with BioBrace® Implant augmentation. It aims to determine if adding the implant improves patient outcomes.

Participant Groups

Group I: BioBrace Augment Group Experimental Treatment 1 Intervention

An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.

Group II: Repair Only Group Placebo Group 1 Intervention

An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Who Is Running the Clinical Trial?

CONMED Corporation

Lead Sponsor

Trials

11

Recruited

1,100+

Findings from Research

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]

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 use of a biodegradable subacromial balloon-shaped spacer (InSpace) during rotator cuff repairs may significantly improve repair strength and reduce failure rates by protecting the tendon repair and centering the humeral head.

This spacer is implanted arthroscopically after the rotator cuff repair, and its correct placement is confirmed by ensuring free arm movement, which helps reduce friction and flatten dog-ear formations at the repair site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial spacer placement for protection of rotator cuff repair. Szöllösy, G., Rosso, C., Fogerty, S., et al.[2022]

A 63-year-old male experienced shoulder pain and stiffness after rotator cuff surgery with bioresorbable anchors, which was linked to a SARS-CoV-2 infection, suggesting a potential viral host response.

Histological analysis revealed a resorption reaction to the anchors and synovitis, but no infection was found, indicating that the symptoms may be related to the body's response to the virus rather than a direct complication from the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SARS-Cov-2 related shoulder pain and stiffness associated to humeral osteolysis after arthroscopic rotator cuff repair: A case report. Lante, E., Mahé, G., Jany, R.[2023]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Arthroscopic Rotator Cuff Repair Using Poly Lactic-co-glycolic Acid Plus β-tricalcium Phosphate Biocomposite Suture Anchors. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Double-Row Rotator Cuff Repair Technique With Dermal Allograft Augmentation. [2023]

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

Subacromial spacer placement for protection of rotator cuff repair. [2022]

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

SARS-Cov-2 related shoulder pain and stiffness associated to humeral osteolysis after arthroscopic rotator cuff repair: A case report. [2023]

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

A Novel Achilles Tendon Repair Technique Utilizing a Bio-Composite Scaffold for a Sub-Acute Tear. [2023]

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

A Novel Distal Biceps Rupture Repair Technique Utilizing a Biocomposite Scaffold. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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