The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear Arthropathy
- Sponsor
- William Beaumont Hospitals
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Postoperative Internal Range of Motion (ROM)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Detailed Description
Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Investigators
Michael Wiater
◾Vice Chairman Orthopedic Surgery◾Chief of Shoulder Surgery ◾Program Director, Fellowship in Shoulder and Elbow Surgery ◾Program Director, Orthopaedic Surgery Residency
William Beaumont Hospitals
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing primary reverse total shoulder arthroplasty
- •Diagnosis of cuff tear arthropathy or primary OA with RCT
- •Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
- •18 years or older
Exclusion Criteria
- •Revision arthroplasty
- •Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- •Minors (under 18 years of age)
- •Prior open shoulder surgery
- •Concomitant latissimus dorsi transfer
- •Patients not undergoing a standard of care physical therapy protocol
- •Pregnant, patient-reported
- •Cognitively impaired
Outcomes
Primary Outcomes
Postoperative Internal Range of Motion (ROM)
Time Frame: 2 years
Internal range of motion measurements of the shoulder in degrees
Postoperative External Range of Motion (ROM)
Time Frame: 2 years
External range of motion measurements of the shoulder in degrees