NCT06748885

Mpact 3D Metal Monolit Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 88 (estimated)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Hip Arthroplasty (THA)

Interventions

Type	Name	Description
DEVICE	Mpact 3D Metal Monolith	THA with Mpact 3D Metal Monolith

Timeline

• Start date: 2024-02-28
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

3 sites across 1 country: France