Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Conditions
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Shoulder Injuries

Intervention / Treatment
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* Device: BioBrace Augmentation
* Procedure: Standard Repair with Sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total Shoulder Arthroplasty Exclusion Criteria: Vulnerable population

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioBrace Augmentation<br>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<br>* 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.<br>* Other names: Implant Group;|
| Active Comparator: Standard Repair with Sutures<br>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<br>* 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.<br>* Other names: Stitch Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in continuity of subscapularis tissue on ultrasound | Continuity of subscapularis tissue on ultrasound | 6 weeks, 6 months after surgery | 
| Difference in thickness of the subscapularis tissue on ultrasound | Thickness of subscapularis tissue on ultrasound | 3 months, 1 years after surgery | 
| Evaluate arthritis on shoulder x-ray | Amount of arthritis or wear patterns on shoulder x-Ray | Surgery | 
| Difference in signs of loosening or wear patterns in shoulder X-Ray | Signs of loosening or wear patterns on shoulder x-ray | 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 3 months, 6 months, 1 year, 2 years after surgery |