Evaluation of a new porous titanium hip implant
Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup
This study is testing a new hip implant made of porous titanium to see if it helps patients recover better and move more easily after hip surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 3 sites (Nantes and 2 other locations) |
| Trial ID | NCT06748885 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the Mpact 3D Metal Monolith cup, a new implant designed for total hip arthroplasty (THA). The study aims to assess the implant's performance in terms of osseointegration, joint stability, and range of motion. By utilizing a porous titanium coating, the implant promotes bone growth and provides enhanced primary stability. The study will involve patients eligible for primary THA and will gather data on their outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 75 who are eligible for primary total hip arthroplasty and covered by the French Social Security system.
Not a fit: Patients with inflammatory arthritis, previous hip surgeries, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and quality of life for patients undergoing total hip arthroplasty.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving hip implant technology and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use) 2. Patient eligible for primary total hip arthroplasty 3. Patient aged between 18 and 75 years 4. Patient covered by the French Social Security system or an equivalent protection scheme. 5. Patient able, in the investigator's opinion, to comply with the requirements of the study. Exclusion Criteria: 1. Patient suffering from inflammatory arthritis 2. Previously operated hip 3. Patient requiring a transplant 4. Hip tumour involved 5. Patient with progressive local or systemic infection 6. Severe acetabular dysplasia 7. Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb. 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 impairment that prevents him/her from fully understanding the requirements of the study 7. Patient living in a geographical area where study follow-up is not possible. 8. Patient taking part in interventional research 9. Minor patient 10. Protected adult patient 11. Vulnerable person according to article L1121-6 of the Public Health Code
Where this trial is running
Nantes and 2 other locations
- Clinique Brétéché — Nantes, France (Not_yet_recruiting)
- Hôpital Lariboisière — Paris, France (Not_yet_recruiting)
- Hôpital Cochin — Paris, France (Recruiting)
Study contacts
- Study coordinator: Philippe Anract
- Email: philippe.anract@aphp.fr
- Phone: 01 58 41 30 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.