Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem
| Registry | NCT04997005 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 550 (Estimated) |
| Sponsor | Medacta International SA (Industry) |
| Conditions | Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head |
| Interventions | AMIStem-P (Device) |
| Dates | start 2019-04-26, primary completion 2029-04-30 (estimated), completion 2032-12-31 (estimated), first posted 2021-08-09, last updated 2025-05-08 |
| Locations | 5 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Arthrosis All trials for Traumatic Arthritis All trials of AMIStem-P
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
Sex: All, ages: 18 Years to 85 Years
Inclusion Criteria: * Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement * Patient eligible to receive an uncemented AMIStem-P femoral stem * Patient agreeing to comply with the study requirements * Patient willing to provide written informed consent * Patient affiliated to a social security system * Patients between 18 and 85 years old Exclusion Criteria: * Participation in biomedical research * Patients younger than 18 years old * Vulnerable adult patients according to article L1121-6 of the French Public Health Code * Pregnant or breastfeeding women * Patients unable to provide written informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| Clinique de Saint Omer | Blendecques | France | |
| Hôpital Castres | Castres | France | |
| Nouvelle Clinique Bordeaux Tondu | Floirac | France | |
| Clinique d'Orange | Orange | France | |
| Hôpital Jacques-Puel | Rodez | France |