Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+ (RTSA-RCR)

Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Injuries; Shoulder Pain
• Intervention / Treatment: Procedure: Reverse Total Shoulder Arthroplasty; Procedure: Rotator Cuff Repair

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 Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Campbell Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects will be patients of either Dr. Brolin or Dr. Throckmorton who had either a reverse total shoulder arthroplasty or rotator cuff repair for treatment of a three tendon tear and are 60 years of age and older.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reverse Total Shoulder Arthroplasty; Retrospective record review and data abstraction of standard of care data preoperative and at least one year postoperative to include patient reported outcomes and range of motion measurements.	Procedure: Reverse Total Shoulder Arthroplasty; standard of care treatment reverse total shoulder arthroplasty delivered
Rotator Cuff Repair; Retrospective record review and data abstraction of standard of care data preoperative to include patient reported outcomes and range of motion measurements. Study invitation will be extended to subjects for completion of a single study visit to collect three patient reported outcomes, range of motion and a ten minute magnetic resonance imaging exam.	Procedure: Rotator Cuff Repair; standard of care treatment rotator cuff repair delivered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder Elbow Surgeons	numeric scale to quantify shoulder function from zero (worst) to one hundred (best)	90 days before surgery to day of surgery
American Shoulder Elbow Surgeons	numeric scale to quantify shoulder function from zero (worst) to one hundred (best)	one year after surgery
Single Assessment Numeric Evaluation	Satisfaction with Shoulder	90 days before surgery to day of surgery
Single Assessment Numeric Evaluation	Satisfaction with Shoulder	one year after surgery
Visual Analog Scale	numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)	90 days before surgery to day of surgery
Visual Analog Scale	numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)	one year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rate	occurrence of repeat surgery	one year after surgery
Sugaya	Measure of tendon quality from one (intact) to five (completely torn)	one year after surgery
Range of motion	shoulder movement measurement	90 day to surgery
Range of motion	shoulder movement measurement	one year after surgery

Collaborators and Investigators

• Sponsor: Campbell Clinic
• Investigators: Principal Investigator: Tyler J Brolin, MD, Campbell Clinic

Publications and helpful links

General Publications

• Allert JW, Sellers TR, Simon P, Christmas KN, Patel S, Frankle MA. Massive Rotator Cuff Tears in Patients Older Than Sixty-five: Indications for Cuff Repair versus Reverse Total Shoulder Arthroplasty. Am J Orthop (Belle Mead NJ). 2018 Dec;47(12). doi: 10.12788/ajo.2018.0109.
• Jacquot A, Dezaly C, Goetzmann T, Roche O, Sirveaux F, Mole D; French Society for Shoulder, Elbow (SOFEC). Is rotator cuff repair appropriate in patients older than 60 years of age? prospective, randomised trial in 103 patients with a mean four-year follow-up. Orthop Traumatol Surg Res. 2014 Oct;100(6 Suppl):S333-8. doi: 10.1016/j.otsr.2014.04.004. Epub 2014 Aug 23.
• Robinson PM, Wilson J, Dalal S, Parker RA, Norburn P, Roy BR. Rotator cuff repair in patients over 70 years of age: early outcomes and risk factors associated with re-tear. Bone Joint J. 2013 Feb;95-B(2):199-205. doi: 10.1302/0301-620X.95B2.30246.
• Gowda CS, Mirza K, Galagali DA. Rotator Cuff Tears: Correlation Between Clinical Examination, Magnetic Resonance Imaging and Arthroscopy. Cureus. 2024 Mar 12;16(3):e56065. doi: 10.7759/cureus.56065. eCollection 2024 Mar.
• Adam MF, Ladermann A, Denard PJ, Lacerda F, Collin P. Preoperative diagnosis and rotator cuff status impact functional internal rotation following reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2024 Jul;33(7):1570-1576. doi: 10.1016/j.jse.2023.11.020. Epub 2024 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Arthralgia; Shoulder Injuries; Shoulder Pain
• Other Study ID Numbers: 25-010480-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No