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Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Clinique Brétéché
Nantes, France
Hôpital Lariboisière
Paris, France
Hôpital Cochin
Paris, France
Start Date
February 28, 2024
Primary Completion Date
December 1, 2030
Completion Date
December 1, 2030
Last Updated
December 27, 2024
88
ESTIMATED participants
Mpact 3D Metal Monolith
DEVICE
Lead Sponsor
Medacta International SA
NCT07347821
NCT07240961
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06768541