NCT04997005Active, not recruiting
The Medacta International AMIStem-P Post-Marketing Surveillance Study
Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 550 (estimated)
- First submitted
- 4 Aug 2021
- Start date
- 26 Apr 2019
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Medacta International SA
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04997005
What you commit to
- Study type: Observational
- Planned participants: 550
- From 26 Apr 2019 to the primary completion date, 30 Apr 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patients younger than 18 years old
Other
- Participation in biomedical research
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique de Saint Omer Coordinator of this site? Confirm its status | Blendecques | France | Unknown status |
| Hôpital Castres Coordinator of this site? Confirm its status | Castres | France | Unknown status |
| Nouvelle Clinique Bordeaux Tondu Coordinator of this site? Confirm its status | Floirac | France | Unknown status |
| Clinique d'Orange Coordinator of this site? Confirm its status | Orange | France | Unknown status |
| Hôpital Jacques-Puel Coordinator of this site? Confirm its status | Rodez | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.