Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+

NCT06848023 | Enrolling By Invitation

• 1 other identifier: 25-010480-XP
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injuries; Shoulder Pain

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

Secondary Outcomes (4)

• Revision rate

  one year after surgery

• Sugaya

  one year after surgery

• Range of motion

  90 day to surgery

• Range of motion

  one year after surgery

Study Arms (2)

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

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

Interventions

Reverse Total Shoulder Arthroplasty PROCEDURE

standard of care treatment reverse total shoulder arthroplasty delivered

Reverse Total Shoulder Arthroplasty

Rotator Cuff Repair PROCEDURE

standard of care treatment rotator cuff repair delivered

Rotator Cuff Repair

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Related Publications (5)

• 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.

  PMID: 30650169 RESULT

• 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.

  PMID: 25155203 RESULT

• 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.

  PMID: 23365029 RESULT

• 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.

  PMID: 38618461 RESULT

• 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.

  PMID: 38218405 RESULT

MeSH Terms

Conditions

Shoulder Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tyler J Brolin, MD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 26, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)