Actively Recruiting
Prospective, Multicenter, Open-Label Study Evaluating the MPACT Dual Mobility Hemispheric Cup for Total Hip Arthroplasty Over 10 Years
Led by Medacta International SA · Updated on 2025-09-29
600
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the 10-year performance of the MPACT Dual Mobility (DM) cup in patients who need total hip arthroplasty. The study aims to measure how long the prosthesis lasts over a decade using the Kaplan Meier curve. Secondary goals include assessing hip function, implant safety, and prosthetic stability. Participants will receive the MPACT DM cup implant during their hip replacement surgery. The study monitors patients before surgery and at multiple follow-up points: 3 months, 1 year, 3 years, 5 years, and 10 years after the procedure. Researchers will evaluate hip function through the Harris Hip Score and examine X-rays to assess bone changes and implant fit using established scoring systems. Throughout the study, participants will have evaluations including clinical assessments, radiographic imaging, and monitoring for complications such as infection or fractures. Data on implant stability and safety will be collected at each visit to track long-term outcomes. Patients will be followed for a full 10 years after their surgery to gather comprehensive information about the implant’s performance and durability.
CONDITIONS
Brief Title
Multicenter Mpact DM France
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a condition appropriate for Medacta implant use according to instructions
- Eligible for first-time total hip replacement surgery
- Aged between 18 and 80 years
- Covered by Social Security or an equivalent health protection plan
- Able to meet the study requirements as judged by the investigator
You will not qualify if you...
- Need for a transplant
- Progressive local or systemic infection
- Muscle loss, neuromuscular disease, or vascular problems in the affected limb making surgery unsafe
- Medical issues that may prevent independent mobility recovery
- Body mass index over 40 kg/m²
- Major cognitive problems preventing understanding of study requirements
- Living where follow-up is not possible
- Participation in other interventional research
- Minor or protected adult status
- Vulnerable person under public health regulations
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay until discharge
Participants undergo total hip arthroplasty using the MPACT Dual Mobility Hemispheric Cup implant and receive immediate post-operative care.
1 surgery visit and hospital stay
Duration - 10 years after the index surgery
Participants are followed for up to 10 years after surgery to evaluate hip function, implant safety, and prosthetic component stability through clinical assessments and radiographs.
Visits at 3 months, 1 year, 3 years, 5 years, and 10 years after surgery
Trial Site Locations
Total: 1 location
1
Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
Dracy-le-Fort, France
Actively Recruiting
Research Team
A
Arianna Girardi
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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