Overview
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
Eligibility
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.
- Patient suffering from active rheumatoid arthritis or osteoporosis.
- Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated.
- Patient suffering from muscle atrophy or neuromuscular disease.
- Patient with an allergy to the implant material.
- Any patient who cannot or does not wish to give their informed consent to participate in the study.
- Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems.
- Any contraindication mentioned in the instructions for use of the investigational medical device.