NCT03111147

Impact of Humeral Component Version on Outcomes Following RTSA

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tear Arthropathy

Interventions

Type	Name	Description
DEVICE	0 degrees humeral component version	RTSA with humeral component positioned in 0 degrees of version
DEVICE	30 degrees humeral component retroversion	RTSA with humeral component positioned in 30 degrees of retroversion

Timeline

• Start date: 2017-05-12
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2017-04-12
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study