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 range18 Years – 80 Years

SexALL

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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
✕. Patient living in a geographical area that does not allow the study follow-up
✕. Patient participating in interventional research.

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