Observational Study on the Long-Term Performance of the Mpact 3D Metal MONOCER Cup in Total Hip Replacement for Adults Under 75

What this Trial Is About

Researchers are studying the long-term performance of the Mpact 3D Metal MonoCER cup used in total hip arthroplasty for patients under 75 years old. This observational study aims to assess how well the implant lasts and functions over a period of 10 years after the surgery. The study focuses on patients receiving this specific metal cup as part of their hip replacement. Participants will receive the Mpact 3D Metal cup as an acetabular shell device during their total hip arthroplasty surgery. The study follows standard treatment practices, and patients who choose not to participate will receive the same care. Follow-up visits are scheduled at 6 months, 1 year, 5 years, and 10 years after surgery to monitor outcomes. During these visits, researchers will check the implants survivorship using Kaplan Meier analysis and assess device stability through radiological exams. They will also evaluate clinical outcomes using the Harris Hip score and monitor safety by collecting any adverse events up to 10 years after surgery. This comprehensive follow-up helps ensure detailed understanding of the devices long-term effects and performance.

A Post Market Surveillance Study About the MONOCER Cup