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
1 other identifier
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2023
CompletedResults Posted
Study results publicly available
March 5, 2024
CompletedMarch 5, 2024
February 1, 2024
6 years
April 7, 2017
February 6, 2024
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Postoperative External Range of Motion (ROM)
External range of motion measurements of the shoulder in degrees
2 years
Postoperative Internal Range of Motion (ROM)
Internal range of motion measurements of the shoulder in degrees
2 years
Study Arms (2)
0 degrees humeral component version
EXPERIMENTALReverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
30 degrees humeral component retroversion
EXPERIMENTALReverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
Interventions
RTSA with humeral component positioned in 0 degrees of version
RTSA with humeral component positioned in 30 degrees of retroversion
Eligibility Criteria
You may qualify if:
- 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
- years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beaumont Health
Royal Oak, Michigan, 48073, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Sloan, Clinical Research Manager
- Organization
- William Beaumont Hospitals
Study Officials
- PRINCIPAL INVESTIGATOR
J. Michael Wiater, MD
Corewell Health East
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ◾Vice Chairman Orthopedic Surgery◾Chief of Shoulder Surgery ◾Program Director, Fellowship in Shoulder and Elbow Surgery ◾Program Director, Orthopaedic Surgery Residency
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 12, 2017
Study Start
May 12, 2017
Primary Completion
May 23, 2023
Study Completion
May 23, 2023
Last Updated
March 5, 2024
Results First Posted
March 5, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share