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Comparing Stability of Cemented BiMobile and Avantage Dual Mobility Cups in Total Hip Replacement Surgery for Older Adults
Led by JointResearch · Updated on 2025-02-28
75
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates how the size of a cemented BiMobile dual mobility cup affects its early stability after total hip arthroplasty THA in patients with hip osteoarthritis. The study compares migration, which indicates loosening, of the BiMobile cup with either a 2 mm or 4 mm cement layer, and also compares these results to the Avantage dual mobility cup with a standard 2 mm cement mantle. The goal is to determine if using more cement improves implant stability and reduces early loosening. Participants will be randomly assigned to one of three groups one receiving the BiMobile cup with a standard size and 2 mm cement mantle, another receiving the BiMobile cup one size smaller with a 4 mm cement mantle, and a third group receiving the Avantage cup with a standard size and 2 mm cement mantle. All cups are implanted following optimal bone preparation reaming. The study is a prospective, single-center, blinded randomized controlled trial. Participants will undergo several follow-up evaluations including X-rays using Radiostereometric Analysis RSA at discharge, 6 weeks, 6 months, 1 year, and 2 years post-surgery to measure cup migration. CT scans will also be taken at discharge and 2 years after surgery to assess migration accuracy. Patient-reported outcomes on physical function, quality of life, pain, and satisfaction will be collected before surgery and at multiple points up to 5 years after surgery. The study aims to monitor implant stability and patient experience over time.
CONDITIONS
Brief Title
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Research Team
L
Loes van Beers, MSc
N
Nienk Willigenburg, PhD
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