Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+

• Conditions: Shoulder Injuries; Shoulder Pain

• Registration Number: NCT06848023
• Lead Sponsor: Campbell Clinic

Brief Summary

To compare the one year outcomes between 60 year old patients with a three tendon tear treated as part of their standard of care with either a reverse total shoulder arthroplasty or rotator cuff repair surgery.

Detailed Description

A retrospective record review will be completed to identify eligible subjects who had either a reverse total shoulder arthroplasty or rotator cuff repair to treat their three tendon tear. Medical record abstraction of standard of care will be completed among the reverse total shoulder arthroplasty cohort. Rotator cuff repair subjects will be contacted with a study invitation and scheduled for a single study visit to collect three patient reported outcomes, assess range of motion and complete a ten-minute magnetic resonance imaging exam following signed consent.

Study Timeline

• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-26
• Study Start: 2025-06-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-28
• Primary Completion: 2026-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• 60 years of age or more at time of surgery
• One year post-reverse total shoulder arthroplasty or one year post-rotator cuff repair involving all three tendons (infraspinatus, supraspinatus, subscapularis)
• Surgery completed by Dr. Tyler Brolin or Dr. Thomas Throckmorton

Exclusion Criteria

• Less than 60 years of age at time of surgery
• Less than one year post-reverse total shoulder arthroplasty or post-rotator cuff repair
• Procedure completed by another provider than Dr. Brolin or Dr. Throckmorton
• Worker's compensation
• Fewer than three tendon tear

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Shoulder Elbow Surgeons	one year after surgery	numeric scale to quantify shoulder function from zero (worst) to one hundred (best)
Single Assessment Numeric Evaluation	one year after surgery	Satisfaction with Shoulder
Visual Analog Scale	one year after surgery	numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)

Secondary Outcome Measures

Name	Time	Method
Revision rate	one year after surgery	occurrence of repeat surgery
Sugaya	one year after surgery	Measure of tendon quality from one (intact) to five (completely torn)
Range of motion	one year after surgery	shoulder movement measurement

Trial Locations

Locations (1)

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States