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Subscapularis Repair Techniques for Shoulder Injuries

N/A

Recruiting

Led By Michael T Freehill, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 6 months after surgery

Awards & highlights

Study Summary

This trial is comparing two methods for repairing the subscapularis muscle and tendon. One method uses a patch and the other does not.

Who is the study for?

This trial is for individuals undergoing total shoulder arthroplasty, which is a type of shoulder replacement surgery. It's not suitable for vulnerable populations such as children, pregnant women, or those unable to consent.Check my eligibility

What is being tested?

The study compares two methods of repairing the subscapularis tissue after shoulder replacement: standard suture repair versus augmentation with a product called BioBrace. The comparison will be based on ultrasound images and clinical outcomes.See study design

What are the potential side effects?

Potential side effects may include typical surgical risks like infection, pain at the site of repair, inflammation, and possible adverse reactions to the BioBrace material if used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 6 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 6 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 6 months after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Difference in continuity of subscapularis tissue on ultrasound

Difference in signs of loosening or wear patterns in shoulder X-Ray

Difference in thickness of the subscapularis tissue on ultrasound

+1 more

Secondary outcome measures

American Shoulder & Elbow Surgeons Score (ASES) score

Shoulder examination for the difference in Active Range of Motion

Shoulder examination for the difference in Passive Range of Motion

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BioBrace AugmentationExperimental Treatment1 Intervention

During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair.

Group II: Standard Repair with SuturesActive Control1 Intervention

During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,216 Total Patients Enrolled

2 Trials studying Shoulder Injuries

106 Patients Enrolled for Shoulder Injuries

Tulane UniversityOTHER

115 Previous Clinical Trials

226,402 Total Patients Enrolled

Michael T Freehill, MDPrincipal InvestigatorStanford University

Media Library

Pitch Patch Augmentation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05487677 — N/A

Shoulder Injuries Research Study Groups: Standard Repair with Sutures, BioBrace Augmentation

Shoulder Injuries Clinical Trial 2023: Pitch Patch Augmentation Highlights & Side Effects. Trial Name: NCT05487677 — N/A

Pitch Patch Augmentation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487677 — N/A

Frequently Asked Questions

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

Are there any participants still needed for this research?

"Unfortunately, this study is not looking for participants at the moment. The listing on clinicaltrials.gov indicates that the trial was posted on September 1st, 2022 and last updated on August 1st, 2022. However, there are 12 other trials which are currently open to enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Michael T. Freehill 2023. "Subscapularis Repair Augmentation for Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487677.