Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study

Arthrex, Inc.6 sites in 1 country134 target enrollmentNovember 14, 2022

ConditionsRotator Cuff Tear Arthropathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff Tear Arthropathy
Sponsor: Arthrex, Inc.
Enrollment: 134
Locations: 6
Primary Endpoint: Constant-Murley Shoulder Outcome Score
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Detailed Description

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative. Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.

Registry

clinicaltrials.gov

Start Date

November 14, 2022

End Date

September 14, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Arthrex, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
•Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
•Patient meets FDA cleared indications for reverse shoulder arthroplasty
•Patient is between 18-100 years old
•Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
•Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning

Exclusion Criteria

•Patient has a history of ipsilateral shoulder arthroplasty
•A history of shoulder septic arthritis
•A full thickness subscapularis tear
•An acute or malunited proximal humeral fracture
•Chronic locked dislocation
•Rheumatoid arthritis
•Axillary nerve damage
•Non-functioning deltoid muscle
•Glenoid vault deficiency precluding baseplate fixation
•Infection and neuropathic joints

Outcomes

Primary Outcomes

Constant-Murley Shoulder Outcome Score

Time Frame: Collected at the 2 year post-op timepoint, and is the primary outcome measure

A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.

Secondary Outcomes

American Shoulder and Elbow Surgeons (ASES) subjective survey(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
Simple Shoulder Test (SST) questionnaire(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
Visual Analog Scale (VAS)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
Ultrasound(Collected once at either the 6 month, 1 year or 2 year timepoint.)
Single Assessment Numeric Evaluation score (SANE)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
Veterans Rand 12 Item Health Survey (VR-12)(Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.)
Standard Pre-Operative Form(Collected at the pre-op visit.)
Return to Work Form(Collected at pre-op, 26 weeks and 1 year.)
Standard Late Postoperative Form(Collected at the 1 year and 2 year timepoints.)