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Procedure

Bridging Reconstruction using BioBrace for Rotator Cuff Tears

N/A

Recruiting

Led By Ivan Wong, MD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

over 18 years of age

magnetic resonance imaging (MRI) proven diagnosis of a large or massive (> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Study Summary

This trial aims to find out if using BioBrace® to fix the gap in rotator cuff tears gives better results for patients compared to the usual repair method. The study will use different measures like

Who is the study for?

This trial is for adults over 18 with a specific shoulder injury: large or massive rotator cuff tears involving two tendons, confirmed by MRI. It's not suitable for those who don't meet the tear size and location criteria.Check my eligibility

What is being tested?

The study compares two methods of treating severe shoulder tendon tears. One uses BioBrace® to bridge gaps in the torn tissue, while the other employs traditional maximal repair techniques. Success will be measured through re-tear rates and improvements in shoulder function.See study design

What are the potential side effects?

Potential side effects may include discomfort at the surgery site, inflammation, infection risk from surgical intervention, and possible adverse reactions to BioBrace® material if one's body rejects it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

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I have a large shoulder tear involving two tendons, confirmed by MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Radiographic or clinical failure

Secondary outcome measures

Acromiohumeral Distance

American Shoulder and Elbow Surgeon survey

Biomechanics and Muscle Activity

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bridging Reconstruction using BioBraceExperimental Treatment1 Intervention

This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.

Group II: RepairActive Control1 Intervention

This group will undergo a rotator cuff repair procedure.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ConMed CorporationIndustry Sponsor

8 Previous Clinical Trials

741 Total Patients Enrolled

Nova Scotia Health AuthorityLead Sponsor

258 Previous Clinical Trials

83,794 Total Patients Enrolled

1 Trials studying Rotator Cuff Tears

60 Patients Enrolled for Rotator Cuff Tears

CONMED CorporationIndustry Sponsor

10 Previous Clinical Trials

1,029 Total Patients Enrolled

1 Trials studying Rotator Cuff Tears

268 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.

Are there any available openings for patients to participate in this medical study?

"Indeed, as documented on clinicaltrials.gov, this study is actively seeking potential participants. The trial was initially posted on December 7th, 2023 and underwent its most recent update on January 11th, 2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, as indicated by the information on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was initially posted on December 7th, 2023 and most recently updated on January 11th, 2024. In total, the study aims to recruit 60 individuals from a single designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maximal Repair Versus Bridging Reconstruction With BioBrace®

Ivan Wong 2023. "Maximal Repair Versus Bridging Reconstruction With BioBrace®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05959733.