A Multicentric, Prospective Clinical Survey on Long Term Performance of an Acetabular Component in Primary Total Hip Arthroplasty

What this Trial Is About

Researchers are evaluating the long-term clinical and radiological performance of the Mpact 3D Metal acetabular component in patients undergoing primary total hip arthroplasty. This study focuses on patients with conditions such as hip primary arthrosis, post-traumatic arthrosis, hip dysplasia, avascular necrosis of the femoral head, and rheumatic arthrosis. The study aims to address challenges like acetabular component loosening, which remains a common cause of failure and revision, by assessing a new biomaterial designed to improve initial stability and bone integration. The intervention involves the implantation of the Mpact 3D Metal cup, a device made using Electron Beam Melting powder technology. This technology creates a high-friction, scratch-fit surface that promotes initial mechanical stability without additional coating. The 3D Metal structure is designed to provide a favorable environment for bone ingrowth, potentially enhancing the durability of the implant. Participants who are candidates for primary total hip arthroplasty and meet the inclusion criteria will receive the Mpact 3D Metal cup during surgery. Participants will be followed for up to 10 years after surgery, with clinical and radiological assessments at 3 months, 1 year, 5 years, 7 years, and 10 years. Researchers will monitor hip physical function, the rate of complications, and the long-term performance of the implant. The study involves regular evaluations to track the implant's integration and function, aiming to provide comprehensive data on the durability and clinical outcomes associated with this new acetabular component.

Mpact 3D Metal Cup PMS