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RECRUITING
NCT06748885

Mpact 3D Metal Monolit Study

Sponsor: Medacta International SA

View on ClinicalTrials.gov

Summary

Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life. Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure. In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation. The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.

Official title: Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

88

Start Date

2024-02-28

Completion Date

2030-12

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

DEVICE

Mpact 3D Metal Monolith

THA with Mpact 3D Metal Monolith

Locations (3)

Clinique Brétéché

Nantes, France

Hôpital Lariboisière

Paris, France

Hôpital Cochin

Paris, France