Shoulder Injuries
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEBioBrace 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.
PROCEDUREStandard 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
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The physician performing the ultrasound evaluation will be blinded to which treatment arm.
Intervention model description
Patients undergoing reverse shoulder arthroplasty will be recruited, consented, & enrolled. Patient will be randomized to standard repair with sutures versus standard repair with BioBrace augmentation of the repair.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total Shoulder Arthroplasty
Exclusion criteria
* Vulnerable population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in continuity of subscapularis tissue on ultrasound | 6 weeks, 6 months after surgery | Continuity of subscapularis tissue on ultrasound |
| Difference in thickness of the subscapularis tissue on ultrasound | 3 months, 1 years after surgery | Thickness of subscapularis tissue on ultrasound |
| Evaluate arthritis on shoulder x-ray | Surgery | Amount of arthritis or wear patterns on shoulder x-Ray |
| Difference in signs of loosening or wear patterns in shoulder X-Ray | 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery | Signs of loosening or wear patterns on shoulder x-ray |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder & Elbow Surgeons Score (ASES) score | 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery | 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 |
| Shoulder examination for the difference in Passive Range of Motion | 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery | Examining passive range of motion - forward flexion, external rotation, abduction |
| Shoulder examination for the difference in Active Range of Motion | 3 months, 6 months, 1 year, 2 years after surgery | Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press |
Countries
United States
Contacts
CONTACTJessica Nguyen
PRINCIPAL_INVESTIGATORMichael T Freehill, MD
Stanford University
Outcome results
None listed