← Back to all trials
Recruiting
NCT05818891
Multicenter Mpact DM France
Conditions: Total Hip Arthroplasty, Survival, Prosthesis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 600
Sponsor: Medacta International SA
Location: Centre Orthopédique Médico-Chirurgical de Dracy Le Fort Dracy-le-Fort
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 Criteria
Inclusion Criteria:
1. Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)
2. Patient eligible for first-line total hip replacement
3. Patient between 18 and 80 years of age
4. Patient covered by the Social Security system or an equivalent protection plan
5. Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study
Exclusion Criteria:
1. Patient requiring a transplant
2. Patient with progressive local or systemic infection
3. Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted
4. Patient with known medical problems that may compromise independent recovery of mobility
5. Patient with a BMI greater than 40 kg/m².
6. Patient with major cognitive problems that do not allow a good understanding of the study requirements
7. Patient living in a geographical area that does not allow the study follow-up
8. Patient participating in interventional research.
9. Minor patient
10. Protected adult patient
11. Vulnerable person according to article L1121-6 of the Public Health Code
12. Pregnant or nursing woman.
Source: ClinicalTrials.gov (NCT05818891). StuddyBuddy aggregates publicly available trial information.