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Procedure

BioBrace Augment Group for Rotator Cuff Tears

N/A

Recruiting

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I have a tear in my shoulder tendon.

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I have had shoulder pain for more than 3 months.

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I have received corticosteroid injections.

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I am between 40 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3-, 6-, and 12-months post-op

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6 Month Retear Rate

Secondary outcome measures

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.

0 / 4Eligibility criteria met

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this medical study currently accepting participants?

"Indeed, as indicated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was originally posted on January 5th, 2024 and underwent its latest update on January 10th, 2024."

Answered by AI

Which specific criteria must individuals meet in order to be considered eligible for participation in this clinical research study?

"This trial aims to recruit a total of 268 individuals aged between 40 and 70 who are diagnosed with rotator cuff tears. It is vital that potential participants meet the following criteria: presence of supraspinatus and/or infraspinatus tendon tears, tear size measuring ≥2 cm but less than 5 cm, ability to comprehend the study's approved Informed Consent Form (ICF), being male or female within the age range specified, experiencing chronic shoulder pain for at least three months, utilization of oral analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, activity adjustments,"

Answered by AI

Is the age criteria for participating in this study limited to individuals below 40 years old?

"To be eligible for participation in this clinical trial, individuals must fall within the age range of 40 to 70. It is worth noting that there are a total of 7 ongoing trials specifically designed for participants under the age of 18, while another set of 102 trials target patients over the age of 65."

Answered by AI

What is the upper limit for the participation count in this medical study?

"Indeed, the details provided by clinicaltrials.gov indicate that this research endeavor is actively seeking eligible participants. The trial was initially posted on January 5th, 2024 and most recently updated on January 10th, 2024. To reach their goals, the study aims to recruit a total of 268 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05997381.