Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT05487677
Status
Recruiting
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Conditions

  • Shoulder Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BioBrace Augmentation — DEVICE
    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.
  • Standard Repair with Sutures — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Dec 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BioBrace Augmentation
    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.
  • Active Comparator: Standard Repair with Sutures
    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.

Primary Outcome Measure

Difference in continuity of subscapularis tissue on ultrasound [ Time Frame: 6 weeks, 6 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94063
Jessica Nguyen
jessn16@@stanford.edu
650-725-0003
Michael Freehill, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Redwood City, CA

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