RecruitingNot Applicable

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

United States268 participantsStarted 2024-01-05

Plain-language summary

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.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female 40 to 70 years old
. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
. Tear of the supraspinatus and/or infraspinatus tendons
. Tear size ≥ 2 cm and \< 5 cm
. Chronic shoulder pain ≥ 3 months
. Failed non-operative treatment of the index shoulder to include one or all of the following:
. Oral analgesics
. Nonsteroidal anti-inflammatory medications (NSAIDs)

Exclusion criteria

. Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
. Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

6 Month Retear Rate

Timeframe: 6 months post-op

Trial details

NCT IDNCT05997381

SponsorCONMED Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Kelley Grynewicz

727-457-4955 BioBraceRCT@ConMed.com

View on ClinicalTrials.gov More Rotator Cuff Tears trials