| NCT ID | NCT05818891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Total Hip Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2018-04-05 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2018-04-05 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Philippe DEROCHE
PRINCIPAL INVESTIGATOR
Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
Frequently Asked Questions
Who can join the NCT05818891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Total Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05818891 currently recruiting?
Yes, NCT05818891 is actively recruiting participants. Contact the research team at girardi@medacta.ch for enrollment information.
Where is the NCT05818891 trial being conducted?
This trial is being conducted at Dracy-le-Fort, France.
Who is sponsoring the NCT05818891 clinical trial?
NCT05818891 is sponsored by Medacta International SA. The principal investigator is Philippe DEROCHE at Centre Orthopédique Médico-Chirurgical de Dracy Le Fort. The trial plans to enroll 600 participants.