Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty
Phase 3
- Conditions
- Arthritis
- Registration Number
- NCT02305966
- Lead Sponsor
- Lawson Health Research Institute
- Brief Summary
Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.
Exclusion Criteria
- will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living >100 km outside of London).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis 24 months
- Secondary Outcome Measures
Name Time Method difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis 24 months