RecruitingNot Applicable

Multicenter Mpact DM France

France600 participantsStarted 2018-04-05

Plain-language summary

The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty. The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)
. Patient eligible for first-line total hip replacement
. Patient between 18 and 80 years of age
. Patient covered by the Social Security system or an equivalent protection plan
. Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study

Exclusion criteria

. Patient requiring a transplant
. Patient with progressive local or systemic infection
. Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted
. Patient with known medical problems that may compromise independent recovery of mobility
. Patient with a BMI greater than 40 kg/m².
. Patient with major cognitive problems that do not allow a good understanding of the study requirements

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.

Timeframe: 10 years after the index surgery

Trial details

NCT IDNCT05818891

SponsorMedacta International SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-04

Contact for this trial

Arianna Girardi

+41 91 696 60 60 girardi@medacta.ch

View on ClinicalTrials.gov More Total Hip Arthroplasty trials