Multicenter Mpact DM France

Launched by MEDACTA INTERNATIONAL SA · Apr 18, 2023

Keywords

ClinConnect Summary

The Multicenter Mpact DM France clinical trial is studying the long-term performance of a specific hip implant called the MPACT DM cup, which is used in total hip replacement surgery. The main goal is to see how long this implant lasts—specifically, researchers want to track it for 10 years. This information can help doctors and patients understand how effective this type of prosthesis is over time.

To participate in this trial, you need to be between 18 and 80 years old and have a condition that requires a hip replacement. You also should be covered by a health insurance plan. However, if you have certain medical issues, such as severe infections or conditions that affect your ability to recover after surgery, you may not be eligible. If you join the trial, you will be monitored closely over the years to evaluate how well the implant is working for you. This research is important as it aims to improve hip replacement surgeries and patient care in the future.

Gender

ALL

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.