Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+

NCT ID: NCT06848023

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-10

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Shoulder Injuries Shoulder Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Reverse Total Shoulder Arthroplasty

Intervention Type PROCEDURE

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.

Rotator Cuff Repair

Intervention Type PROCEDURE

standard of care treatment rotator cuff repair delivered

Interventions

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Reverse Total Shoulder Arthroplasty

standard of care treatment reverse total shoulder arthroplasty delivered

Intervention Type PROCEDURE

Rotator Cuff Repair

standard of care treatment rotator cuff repair delivered

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campbell Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyler J Brolin, MD

Role: PRINCIPAL_INVESTIGATOR

Campbell Clinic

Locations

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Campbell Clinic

Germantown, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30650169 (View on PubMed)

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.

Reference Type RESULT
PMID: 25155203 (View on PubMed)

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.

Reference Type RESULT
PMID: 23365029 (View on PubMed)

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.

Reference Type RESULT
PMID: 38618461 (View on PubMed)

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.

Reference Type RESULT
PMID: 38218405 (View on PubMed)

Other Identifiers

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25-010480-XP

Identifier Type: -

Identifier Source: org_study_id

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