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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
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.
Stanford University
Redwood City, California, United States
RECRUITINGDifference 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
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Time frame: 3 months, 6 months, 1 year, 2 years after surgery