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Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

NCT05487677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-03

No results posted yet for this study

Summary

The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.

Conditions

  • Shoulder Injuries

Interventions

DEVICE

BioBrace Augmentation

During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material.

PROCEDURE

Standard Repair with Sutures

During shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment.

Sponsors & Collaborators

Principal Investigators

  • Michael T Freehill, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-09-01
Completion
2028-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487677 on ClinicalTrials.gov