Clinical trial NCT06848023: Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+
Official title: Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Injuries
Shoulder Pain
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: American Shoulder Elbow Surgeons
timeFrame: 90 days before surgery to day of surgery
measure: American Shoulder Elbow Surgeons
timeFrame: one year after surgery
measure: Visual Analog Scale
timeFrame: 90 days before surgery to day of surgery
measure: Visual Analog Scale
timeFrame: one year after surgery
measure: Single Assessment Numeric Evaluation
timeFrame: 90 days before surgery to day of surgery
measure: Single Assessment Numeric Evaluation
timeFrame: one year after surgery
Secondary outcomes:
measure: Revision rate
timeFrame: one year after surgery
measure: Sugaya
timeFrame: one year after surgery
measure: Range of motion
timeFrame: 90 day to surgery
measure: Range of motion
timeFrame: one year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Campbell Clinic
name: Tyler J Brolin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.