Arthritis
Conditions
Keywords
advanced arthritis, shoulder
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.
Interventions
PROCEDUREsurgery
All patients will receive a Delta XTEND reverse shoulder implant
DEVICE0.8 mm diameter Tantalum marker beads
At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis | 24 months |
Contacts
Primary ContactKate Kelly, M.Sc,MPH/Gero
Outcome results
None listed