Impact of Humeral Component Version on Outcomes Following RTSA

NCT ID: NCT03111147

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2023-05-23

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.

Conditions

Rotator Cuff Tear Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

0 degrees humeral component version

Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version

Group Type: EXPERIMENTAL

0 degrees humeral component version

Intervention Type: DEVICE

RTSA with humeral component positioned in 0 degrees of version

30 degrees humeral component retroversion

Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion

Group Type: EXPERIMENTAL

30 degrees humeral component retroversion

Intervention Type: DEVICE

RTSA with humeral component positioned in 30 degrees of retroversion

Interventions

0 degrees humeral component version

RTSA with humeral component positioned in 0 degrees of version

Intervention Type: DEVICE

30 degrees humeral component retroversion

RTSA with humeral component positioned in 30 degrees of retroversion

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Michael Wiater

◾Vice Chairman Orthopedic Surgery◾Chief of Shoulder Surgery ◾Program Director, Fellowship in Shoulder and Elbow Surgery ◾Program Director, Orthopaedic Surgery Residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Michael Wiater, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Health

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-057

Identifier Type: -

Identifier Source: org_study_id