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NCT03111147 Clinical Trial

Impact of Humeral Component Version on Outcomes Following RTSA

Rotator Cuff Tear Arthropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03111147
Other study ID # 2017-057
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2017
Est. completion date May 23, 2023

Study information
Verified date February 2024
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 95
Est. completion date May 23, 2023
Est. primary completion date May 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 0 degrees humeral component version
RTSA with humeral component positioned in 0 degrees of version
• 30 degrees humeral component retroversion
RTSA with humeral component positioned in 30 degrees of retroversion

Locations
Country Name City State
United States Beaumont Health Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative External Range of Motion (ROM) External range of motion measurements of the shoulder in degrees 2 years
Primary Postoperative Internal Range of Motion (ROM) Internal range of motion measurements of the shoulder in degrees 2 years
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