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Polarstem Versus Corail; a Comparison of Micromotion and Periprosthetic Bone Remodelling of Two Femoral Stems
Sponsor: Helse-Bergen HF
Summary
A randomised controlled trial comparing a recently introduced femoral stem with an established stem for total hip arthroplasty (THA). 60 patients will be randomised into one of the two groups 1. Polarstem uncemented femoral stem (Smith \& Nephew) 2. Corail uncemented femoral stem (De Puy) All patients will receive a 32mm cobalt-chromium (CoCr) femoral head and an R3 acetabular cup with a 10 Mrad highly cross-linked polyethylene (XLPE) liner (Smith \& Nephew). Radiostereometric analysis (RSA) will be used to measure stem migration. Dual-energy x-ray absorptiometry (DXA) measurements will be used to measure bone mineral density. Clinical outcome will be assessed at different time point to evaluate satisfaction and function. Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.
Official title: The Polarstem Versus Corail; a Comparison of Micromotion and Periprosthetic Bone Remodelling of Two Femoral Stems. A Randomised Trial of 60 Patients Using Radiostereometric Analysis, Dual Energy X-ray Absorptiometry and Computer Tomography
Key Details
Gender
All
Age Range
Any - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2017-06-20
Completion Date
2033-01-31
Last Updated
2025-01-20
Healthy Volunteers
No
Conditions
Interventions
Polarstem
Stem used in total hip replacement. Manufacturer: Smith \& Nephew Orthopaedics AG, Baar, Switzerland.
Corail
Stem used in total hip replacement. Manufacturer: De Puy Int Ltd, Leeds, UK.
Locations (1)
Helse Bergen HF
Bergen, Postbox 1400, Norway