Impact of Humeral Component Version on Outcomes Following RTSA

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial

Conditions
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Rotator Cuff Tear Arthropathy

Intervention / Treatment
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* Device: 0 degrees humeral component version
* Device: 30 degrees humeral component retroversion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0 degrees humeral component version<br>Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version | Device: 0 degrees humeral component version<br>* RTSA with humeral component positioned in 0 degrees of version<br>|
| Experimental: 30 degrees humeral component retroversion<br>Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion | Device: 30 degrees humeral component retroversion<br>* RTSA with humeral component positioned in 30 degrees of retroversion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative ROM | External and internal range of motion measurements of the shoulder | 2 years |