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Enrolling by invitation NCT06848023

Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+

— Observational Shoulder Injuries Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reverse Total Shoulder Arthroplasty, Rotator Cuff Repair.
Who it may be relevant to
Registry conditions: Shoulder Injuries, Shoulder Pain. Basic parameters: 60 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Reverse Total Shoulder Arthroplasty
    standard of care treatment reverse total shoulder arthroplasty delivered
  • Procedure Rotator Cuff Repair
    standard of care treatment rotator cuff repair delivered

Primary outcome measures

  • American Shoulder Elbow Surgeons [Time frame: 90 days before surgery to day of surgery]
  • American Shoulder Elbow Surgeons [Time frame: one year after surgery]
  • Visual Analog Scale [Time frame: 90 days before surgery to day of surgery]
  • Visual Analog Scale [Time frame: one year after surgery]
  • Single Assessment Numeric Evaluation [Time frame: 90 days before surgery to day of surgery]
  • Single Assessment Numeric Evaluation [Time frame: one year after surgery]
Secondary outcome measures (4)
  • Revision rate [Time frame: one year after surgery]
  • Sugaya [Time frame: one year after surgery]
  • Range of motion [Time frame: 90 day to surgery]
  • Range of motion [Time frame: one year after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Campbell Clinic — Germantown

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. PMID 30650169
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06848023 · 25-010480-XP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗