💬In plain words
What the trial is, and whether it could suit you
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
HealthTeky