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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis Shoulder

• 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