Actively Recruiting
Mpact 3D Metal Monolit Study
Led by Medacta International SA · Updated on 2024-12-27
88
Participants Needed
3
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mpact 3D Metal Monolit Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
- Patient eligible for primary total hip arthroplasty
- Patient aged between 18 and 75 years
- Patient covered by the French Social Security system or an equivalent protection scheme
- Patient able, in the investigator's opinion, to comply with the requirements of the study
You will not qualify if you...
- Patient suffering from inflammatory arthritis
- Previously operated hip
- Patient requiring a transplant
- Hip tumour involved
- Patient with progressive local or systemic infection
- Severe acetabular dysplasia
- Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb
- Patient with known medical problems that may compromise independent recovery of mobility
- Patient with a BMI greater than 40 kg/m�b2
- Patient with major cognitive impairment preventing full understanding of the study
- Patient living in a geographical area where study follow-up is not possible
- Patient taking part in interventional research
- Minor patient
- Protected adult patient
- Vulnerable person according to article L1121-6 of the Public Health Code
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Clinique Brétéché
Nantes, France, 44000
Not Yet Recruiting
2
Hôpital Lariboisière
Paris, France, 75010
Not Yet Recruiting
3
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
Research Team
P
Philippe Anract
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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