Back to resultsImpact of Humeral Component Version on Outcomes Following RTSA
Primary Purpose
Rotator Cuff Tear Arthropathy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0 degrees humeral component version
30 degrees humeral component retroversion
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Arthropathy
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
Sites / Locations
- Beaumont Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
0 degrees humeral component version
30 degrees humeral component retroversion
Arm Description
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
Outcomes
Primary Outcome Measures
Postoperative ROM
External and internal range of motion measurements of the shoulder
Secondary Outcome Measures
Full Information
NCT ID
NCT03111147
First Posted
April 7, 2017
Last Updated
February 24, 2023
Sponsor
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03111147
Brief Title
Impact of Humeral Component Version on Outcomes Following RTSA
Official Title
The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0 degrees humeral component version
Arm Type
Experimental
Arm Description
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
Arm Title
30 degrees humeral component retroversion
Arm Type
Experimental
Arm Description
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
Intervention Type
Device
Intervention Name(s)
0 degrees humeral component version
Intervention Description
RTSA with humeral component positioned in 0 degrees of version
Intervention Type
Device
Intervention Name(s)
30 degrees humeral component retroversion
Intervention Description
RTSA with humeral component positioned in 30 degrees of retroversion
Primary Outcome Measure Information:
Title
Postoperative ROM
Description
External and internal range of motion measurements of the shoulder
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Michael Wiater, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Humeral Component Version on Outcomes Following RTSA
We'll reach out to this number within 24 hrs