Evaluating the 10-year performance of the MPACT DM hip prosthesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the long-term performance of the MPACT DM cup in patients undergoing total hip arthroplasty over a 10-year period. The primary endpoint is the lifespan of the prosthesis, evaluated using the Kaplan Meier curve. Secondary objectives include assessing hip function, implant safety, and stability through various scoring systems and radiographic evaluations. The study will involve patients who meet specific eligibility criteria and will be monitored for their recovery and outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
  Dracy-le-Fort, France Recruiting

Study contacts

• Principal investigator: Philippe DEROCHE — Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
• Study coordinator: Arianna Girardi
• Email: girardi@medacta.ch
• Phone: +41 91 696 60 60

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intraoperative methadone for pain control after total hip replacement

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.