Subscapularis Repair Augmentation for Total Shoulder Arthroplasty
This study is looking at ways to improve shoulder replacement surgery. Researchers want to compare two methods for repairing the subscapularis (a rotator cuff muscle) during surgery. One method uses a standard repair with stitches. The other method uses a BioBrace Augmentation, which is a special synthetic and biologic scaffold, in addition to stitches. The main goal is to see if the BioBrace leads to better healing of the subscapularis muscle, as seen on ultrasound images. They will also look for any differences in how patients feel and function. You may be able to join if you are an adult having total shoulder arthroplasty. The study aims to enroll 100 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 100 participants. It compares two different surgical repair methods.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least one year after surgery, with ultrasound measurements at 6 weeks, 3 months, 6 months, and 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Subscapularis Repair Augmentation for Total Shoulder Arthroplasty
At a glance
Conditions
NCT05487677
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Stanford University
Redwood City, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Michael T Freehill, MD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Difference in continuity of subscapularis tissue on ultrasound6 weeks, 6 months after surgery
Continuity of subscapularis tissue on ultrasound
- Difference in thickness of the subscapularis tissue on ultrasound3 months, 1 years after surgery
Thickness of subscapularis tissue on ultrasound
- Evaluate arthritis on shoulder x-raySurgery
Amount of arthritis or wear patterns on shoulder x-Ray
- Difference in signs of loosening or wear patterns in shoulder X-Ray2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Signs of loosening or wear patterns on shoulder x-ray