AMIStem-H Radiological Assessment
Active, not recruiting
- Conditions
- Hip Replacement Arthroplasty
- Registration Number
- NCT03505580
- Lead Sponsor
- Medacta International SA
- Brief Summary
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.
All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
- patients bearing an AMIStem-H cementless femoral stem
Exclusion Criteria
- patients who refuse to give consent for the treatment of data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of radiolucencies 5 years
- Secondary Outcome Measures
Name Time Method evaluation of radiolucent lines progression 5 years, 10 years Record of adverse events 1, 5 years and 10 years correlation between the presence of radiolucencies and patient/implant characteristics 5 years, 10 years
Trial Locations
- Locations (2)
Clinique du Cèdre
🇫🇷Bois Guillaume, France
Clinique Paris V
🇫🇷Paris, France