Comparing Hip Replacement Stability Using Ancillary Screws and Stem Migration in Patients Aged 65 to 80 Years

What this Trial Is About

Researchers are evaluating the use of ancillary screws in the ACE acetabulum cup of a total hip replacement surgery for patients aged 65 to 80 with hip osteoarthritis. The study aims to compare implant migration and early fixation of a hybrid hip replacement combining an uncemented ACE acetabular component with a cemented Avanteon femoral stem. This is done using a new CT-based Radiostereometric Analysis CT-RSA method, which may help predict the long-term survival of these implants and reduce the need for revision surgeries. Participants will undergo total hip arthroplasty and be randomly assigned to receive either the acetabular component with ancillary screws or without screws. The study will use CT-RSA, plain X-rays, and patient-reported outcome measures to assess implant stability and migration over time. Additionally, patient activity will be monitored with an accelerometer-based device to evaluate if screw fixation affects activity levels. The study also aims to test the precision of an ultra-low dose CT-RSA to reduce radiation exposure. During the study, participants will have scheduled clinical and radiographic evaluations including CT scans and X-rays at regular intervals over two years. Researchers will measure implant translation, rotation, and migration to assess fixation and stability. Patient activity levels and safety will also be monitored. The goal is to provide data that supports improvements in hip implant design and durability, potentially reducing revision surgery and associated complications. Total participation lasts at least two years with ongoing assessments and monitoring.

The Ace Avanteon Study - A Randomized Controled Trial