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

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

This study is testing how well the MPACT DM hip implant works over 10 years for people who have had hip replacement surgery.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Medacta International SA (industry)
• Locations: 1 site (Dracy-le-Fort)
• Trial ID: NCT05818891 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 18 to 80 who are eligible for first-line total hip replacement and meet the criteria for Medacta implants.

Not a fit: Patients who may not benefit from this study include those requiring a transplant, those with significant comorbidities affecting recovery, or those with a BMI greater than 40 kg/m².

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the longevity and effectiveness of the MPACT DM hip prosthesis, potentially improving patient outcomes in hip replacement surgeries.

How similar studies have performed: Other studies evaluating the long-term performance of hip prostheses have shown success, indicating that this approach is supported by existing evidence.

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.

Where this trial is running

Dracy-le-Fort

• 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

Conditions: Total Hip Arthroplasty, Survival, Prosthesis