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ID05818891

Study to Evaluate the 10-Year Performance and Safety of the MPACT Dual Mobility Cup in Patients Undergoing Total Hip Replacement

Led by Medacta International SA · Updated on 2025-09-29

600

Participants Needed

1

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the 10-year performance of the MPACT Dual Mobility DM cup in patients who need total hip arthroplasty. The study aims to measure how long the prosthesis lasts over a decade using the Kaplan Meier curve. Secondary goals include assessing hip function, implant safety, and prosthetic stability. Participants will receive the MPACT DM cup implant during their hip replacement surgery. The study monitors patients before surgery and at multiple follow-up points 3 months, 1 year, 3 years, 5 years, and 10 years after the procedure. Researchers will evaluate hip function through the Harris Hip Score and examine X-rays to assess bone changes and implant fit using established scoring systems. Throughout the study, participants will have evaluations including clinical assessments, radiographic imaging, and monitoring for complications such as infection or fractures. Data on implant stability and safety will be collected at each visit to track long-term outcomes. Patients will be followed for a full 10 years after their surgery to gather comprehensive information about the implants performance and durability.

CONDITIONS

Brief Title

Multicenter Mpact DM France

Research Team

A

Arianna Girardi

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