← Back to Search

Procedure

BioBrace® Implant for Rotator Cuff Tears (REinForce Trial)

N/A
Waitlist Available
Research Sponsored by CONMED Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tear of the supraspinatus and/or infraspinatus tendons
Chronic shoulder pain ≥ 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3-, 6-, and 12-months post-op

Summary

This trial is testing a new type of implant called BioBrace® to see if it is safe and effective for repairing a torn rotator cuff. The implant will be compared to the usual surgery for

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the surgery site, infection risk from implants or surgical procedures, inflammation around the implant area and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a tear in my shoulder tendon.
Select...
I have had shoulder pain for more than 3 months.
Select...
I have received corticosteroid injections.
Select...
I am between 40 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3-, 6-, and 12-months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3-, 6-, and 12-months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6 Month Retear Rate
Secondary study objectives
12 Month Retear Rate
EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)
Single Assessment Numeric Evaluation (SANE)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BioBrace Augment GroupExperimental Treatment1 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 GroupPlacebo Group1 Intervention
An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Find a Location

Who is running the clinical trial?

CONMED CorporationLead Sponsor
10 Previous Clinical Trials
821 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
60 Patients Enrolled for Rotator Cuff Tears
~173 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top