Actively Recruiting
Study Evaluating the Function and Stability of the Mpact 3D Metal Monolith Cup in Total Hip Arthroplasty A Prospective, Multicenter, Observational 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 a common orthopedic surgery aimed at improving patients' quality of life. This research focuses on assessing the function and stability of the Mpact 3D Metal Monolith cup, a new implant designed with a porous titanium coating to enhance bone integration and provide better joint stability. The study collects clinical and radiological data over several years to evaluate the implant's performance and survival in patients undergoing hip replacement. Participants receive total hip arthroplasty using the Mpact 3D Metal Monolith device. This implant offers higher porosity than standard coatings, promoting bone growth and increased stability. The design aims to improve the range of motion, reduce dislocation risk, and support long-term bone fixation. The study observes patients for up to five years after surgery to monitor outcomes. During the study, hip function is evaluated before surgery and at multiple follow-up points: 3 months, 6 months, 1 year, 2 years, and 5 years. Researchers monitor clinical and radiological indicators to assess implant stability and hip performance. Participants' adherence to study requirements is also tracked to ensure accurate and comprehensive data collection throughout the observation period.
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
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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
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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