NCT04728282

Comparison of Lateralized RTSA With and Without Subscapularis Repair

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Panam Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arthritis Shoulder

Interventions

Type	Name	Description
PROCEDURE	RTSA with subscapularis repair	Lateralized reverse total shoulder arthroplasty with repair of subscapularis
PROCEDURE	RTSA without subscapularis repair	Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Timeline

• Start date: 2021-11-01
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2021-01-28
• Last updated: 2026-02-25

Locations

1 site across 1 country: Canada