BioBrace® Implant for Rotator Cuff Tears

(REinForce Trial)

Overseen By Evona Wojtanowski

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to repair torn rotator cuffs in the shoulder using an implant called BioBrace®. Researchers aim to determine if adding BioBrace® during surgery is safer and more effective than standard repair surgery alone. The trial targets individuals with ongoing shoulder pain for at least three months, a specific type of rotator cuff tear, and no relief from other treatments like pain medication or physical therapy. As an unphased trial, it offers patients the chance to explore innovative treatment options that could potentially enhance their quality of life.

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 prior data suggests that the BioBrace® Implant is safe for rotator cuff repair?

Research has shown that the BioBrace® Implant used in rotator cuff repair is generally well-received by patients. One study observed 267 patients and reported positive results. Most patients experienced significant improvements in shoulder function, with 91.7% improving enough to ease everyday activities.

Additionally, reports indicate major improvements in pain and shoulder function one year after surgery with the BioBrace® Implant. These findings suggest that the implant is generally safe and enhances shoulder movement while reducing pain post-surgery. Studies have not identified any major safety issues, offering reassurance to those considering participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the BioBrace® Implant for rotator cuff tears because it offers a novel way to enhance the standard surgical repair. Unlike traditional methods that rely solely on stitching the torn tendon back together, the BioBrace® Implant provides an additional layer of support by being fixed on top of the repaired tendon. This implant uses a unique scaffold design that might promote better healing and strengthen the repaired area more effectively, potentially leading to improved recovery outcomes for patients.

What evidence suggests that the BioBrace® Implant is effective for rotator cuff tears?

Research has shown that the BioBrace® Implant, which participants in this trial may receive, may improve recovery for rotator cuff tears. In one study, 91.7% of patients with the BioBrace® Implant experienced noticeable improvements in shoulder function, suggesting it could heal better than traditional methods. Additionally, evidence indicates that the BioBrace® can reduce the risk of retears, a common issue with rotator cuff repairs. This new method uses a special support structure that aids the tendon in healing and maintaining strength. These findings suggest that the BioBrace® Implant could be a good option for those needing rotator cuff repair. Meanwhile, another group in this trial will receive the standard arthroscopic rotator cuff repair without the BioBrace® Implant. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

Citations

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ctv.veeva.com

ctv.veeva.com/study/biobrace-r-implant-for-arthroscopic-repair-of-full-thickness-rotator-cuff-tears

BioBrace® Implant for Arthroscopic Repair of Full Thickness ...

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff ...

2.

withpower.com

withpower.com/trial/biobrace-implant-for-rotator-cuff-tears-e9aa6

BioBrace® Implant for Rotator Cuff Tears (REinForce Trial)

Patients showed significant improvement in shoulder function, with 91.7% meeting the minimally clinically important difference in the American Shoulder and ...

3.

conmed.com

conmed.com/en/products/implants-and-suture-anchors/biobrace/biobrace-data

BioBrace Clinical Evidence: Reinforced Healing

According to a white paper based on meta-analysis and a retrospective review of data, rotator cuff retear rates after surgical repair can range from 7.2% to 94% ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10123441/

Resorbable Bioinductive Collagen Implant Is Cost Effective ...

The base case analysis demonstrated that RBI results in improved healing/retear rates, with more patients achieving a successfully healed ...

5.

journaloei.scholasticahq.com

journaloei.scholasticahq.com/article/38244-surgical-repair-and-augmentation-of-a-large-type-2-re-tear-of-the-rotator-cuff-with-a-novel-biocomposite-scaffold-a-case-report

Surgical Repair and Augmentation of a Large Type-2 Re- ...

The use of a novel biocomposite scaffold augmentation for revision rotator cuff repair demonstrated evidence of healing, incorporation, and remodeling.

6.

conmed.com

conmed.com/-/media/conmed/documents/clinical/retrospectivechartreviewtoevaluateclinicaloutcomesofbiobrace_whitepaper.ashx

Retrospective Chart Review to Evaluate Clinical Outcomes ...

Medical records were reviewed with outcomes documented in 267 patients from four surgeons across four different United. States health care facilities who ...

7.

conmed.com

conmed.com/en/data-repository

Clinical Data Repository

A Retrospective Chart Review was undertaken to evaluate safety and clinical outcomes of the BioBrace® Implant across various applications. View. Rotator Cuff ...