N/A
N=85
Impact of Humeral Component Version on Outcomes Following RTSA
Rotator Cuff Tear Arthropathy
Bottom Line
View on ClinicalTrials.gov: NCT03111147 ↗Enrolled (actual)
85
Serious AEs
4.7%
Results posted
Mar 2024
Primary outcome: Primary: Postoperative External Range of Motion (ROM) — 35; 39 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0 degrees humeral component version (Device); 30 degrees humeral component retroversion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative External Range of Motion (ROM) |
35; 39 | — |
| PRIMARY Postoperative Internal Range of Motion (ROM) |
35.5; 33.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03111147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.