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RecruitingNCT05818891

Multicenter Mpact DM France

Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup

Sponsor

Medacta International SA

Enrollment

600 participants

Start Date

Apr 5, 2018

Study Type

OBSERVATIONAL

Conditions

Total Hip ArthroplastySurvival, Prosthesis

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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.
  • Minor patient
  • Protected adult patient
  • Vulnerable person according to article L1121-6 of the Public Health Code
  • Pregnant or nursing woman.
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Locations(1)

Centre Orthopédique Médico-Chirurgical de Dracy Le Fort

Dracy-le-Fort, France

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NCT05818891

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