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Comparison of Lateralized RTSA With and Without Subscapularis Repair

Arthritis Shoulder Clinical Trial

Official title:
Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair

Clinical Trial Summary

The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.

Clinical Trial Description

The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are: Specific Aim 1: To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period. Specific Aim 2: To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period. Specific Aim 3: To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period. Specific Aim 4: To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period. Specific Aim 5: To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04728282
Study type Interventional
Source Panam Clinic
Contact Sheila McRae, PhD
Phone 204-925-7469
Email smcrae@panamclinic.com
Status Recruiting
Phase Early Phase 1
Start date November 1, 2021
Completion date May 1, 2027
View Details
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