Study of Bone Changes Around 3D-Printed Highly-Porous Titanium vs Standard HydroxyapatiteTitanium Acetabular Cups in Total Hip Replacement

What this Trial Is About

This research aims to evaluate the changes in bone mineral density around two types of acetabular cups used in primary total hip arthroplasty. The study compares a 3D-printed highly-porous trabecular titanium cup with a standard hydroxyapatitetitanium plasma-sprayed cup. It focuses on how bone remodeling occurs up to two years after surgery to understand differences in implant integration and longevity. Participants will be randomly assigned to receive either the investigational Jump System Traserae cup, a press-fit, cementless 3D-printed highly-porous titanium device, or the control Jump System HAX-Poreae cup, a press-fit, cementless hydroxyapatitetitanium plasma-sprayed cup. Both cups have the same design, and treatments are administered during unilateral primary total hip arthroplasty. The study will follow patients for two years, with bone density measured at multiple time points. Patients will undergo DEXA scans before discharge and at 1 week, 3 months, 6 months, 12 months, and 24 months after surgery to measure bone mineral density in four regions around the cup. Researchers will also assess clinical outcomes using the Harris hip score and look for signs of osseointegration at 12 and 24 months. The trial involves detailed monitoring of bone remodeling and implant integration during the two-year follow-up period.

Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty