Impact of Humeral Component Version on Outcomes Following RTSA

Not Applicable

Completed

• Conditions: Rotator Cuff Tear Arthropathy
• Interventions: Device: 0 degrees humeral component version; Device: 30 degrees humeral component retroversion

• Registration Number: NCT03111147
• Lead Sponsor: William Beaumont Hospitals

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.

Study Timeline

• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Study Start: 2017-05-12
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Status Verified: 2024-02
• Results First Submitted: 2024-02-06
• Results First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Results First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0 degrees humeral component version	0 degrees humeral component version	Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
30 degrees humeral component retroversion	30 degrees humeral component retroversion	Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion

Primary Outcome Measures

Name	Time	Method
Postoperative Internal Range of Motion (ROM)	2 years	Internal range of motion measurements of the shoulder in degrees
Postoperative External Range of Motion (ROM)	2 years	External range of motion measurements of the shoulder in degrees

Trial Locations

Locations (1)

Beaumont Health; 🇺🇸 Royal Oak, Michigan, United States