Randomized Trial Comparing Ceramic Modular Dual Mobility vs Standard Polyethylene Inserts in Cementless Total Hip Replacement for Primary Coxarthrosis

What this Trial Is About

This trial evaluates primary coxarthrosis patients receiving cementless total hip arthroplasty THA. It compares modular dual mobility inserts with ceramic multilayer coating against standard polyethylene inserts with metal heads. The study aims to assess if cobalt and chromium serum metal ion levels with the dual mobility system are similar to those with standard metal-on-polyethylene implants, as metal ion release is a concern and previous studies lacked a proper control group. Participants will be randomly assigned to receive either the Dual Mobility Cup device or the Standard Acetabular component device that includes polyethylene with vitamin E inlay and a metal head. Both interventions are established options in THA for conditions like coxarthrosis, rheumatic arthritis, hip fractures, and femoral head necrosis. The trial involves the use of cementless acetabular cups and will follow patients over several years. During the study, participants will undergo blood tests to measure serum cobalt and chromium levels at 12 months post-surgery. Functional outcomes will be assessed using the Harris Hip Score at 3 months, 12 months, and 3 years after surgery. Gait analysis and patient satisfaction evaluations will be performed before surgery and during follow-up visits. Radiologic assessments of cup positioning, radiolucencies, and heterotopic ossification will be done immediately post-op and at multiple intervals up to 3 years. Participants will be monitored for adherence and safety throughout the study duration, which extends to at least 3 years after surgery.

Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)