NCT06640764
Recruiting
Not Applicable
Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysplasia of Hip Joint
- Sponsor
- Medacta International SA
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Survival rate of SMS femoral stem
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.
- •Patient who will receive a Medacta SMS femoral stem.
- •Patient agrees to comply with the study requirements.
- •Patient has signed the consent form.
- •Patient is affiliated with a social security system.
- •Patient aged 18 to 75 years
Exclusion Criteria
- •Participation in biomedical research.
- •Minor patient.
- •Protected adult patient.
- •Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.
- •Pregnant or breastfeeding women.
- •Patient unable to express their non-opposition.
- •Patient refusing the collection of their personal data.
- •Acute, systemic, or chronic infection. Skeletal immaturity.
- •Grossly deformed anatomy (at the surgeon's discretion).
- •Osteomalacia for which the fixation of an uncemented implant is contraindicated.
Outcomes
Primary Outcomes
Survival rate of SMS femoral stem
Time Frame: From enrollment to the end of treatment at 10 years
Survival analysis accordin to the Kaplan-Meier method
Secondary Outcomes
- Evaluation of the clinical performance of the SMS femoral stem(From enrollment to the end of treatment at 10 years)
- Evaluation of the hip function(From enrollment to the end of treatment at 10 years)
- Evaluation of the quality of life(From enrollment to the end of treatment at 10 years)
- Evaluation of the safety (adverse events) of the SMS femoral stem(From enrollment to the end of treatment at 10 years)
- Evaluation of the stability and the fixation of the SMS femoral stem(From enrollment to the end of treatment at 10 years)
Study Sites (1)
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