An interventional study of BioBrace Augmentation and Standard Repair with Sutures in Shoulder Injuries, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.
114 studies on the registry are indexed under Shoulder Injuries; 31 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 65 interventional studies indexed under Shoulder Injuries.
Browse Shoulder Injuries studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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 standard repair, patient will receive the standard repair with sutures.
Procedure: Standard Repair with Sutures
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.
Also known as: Implant Group
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.
Also known as: Stitch Group
Difference in continuity of subscapularis tissue on ultrasound
Continuity of subscapularis tissue on ultrasound
Time frame: 6 weeks, 6 months after surgery
Difference in thickness of the subscapularis tissue on ultrasound
Thickness of subscapularis tissue on ultrasound
Time frame: 3 months, 1 years after surgery
Evaluate arthritis on shoulder x-ray
Amount of arthritis or wear patterns on shoulder x-Ray
Time frame: Surgery
Difference in signs of loosening or wear patterns in shoulder X-Ray
Signs of loosening or wear patterns on shoulder x-ray
Time frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
American Shoulder & Elbow Surgeons Score (ASES) score
is a 100-point scale that consists of two dimensions: pain and activities of daily living. 0 indicates worse shoulder condition and 100 indicates best shoulder condition. The greater the score, the lower the level of shoulder disability
Time frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Passive Range of Motion
Examining passive range of motion - forward flexion, external rotation, abduction
Time frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Active Range of Motion
Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press
Time frame: 3 months, 6 months, 1 year, 2 years after surgery
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