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Recruiting
NCT06640764
Multicentre SMS Study - FR
Conditions: Dysplasia of Hip Joint, Hip Osteoarthritis, Traumatic Arthritis of Hip, Avascular Necrosis of Femur Head
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Enrollment: 260
Sponsor: Medacta International SA
Location: Clinique de l'Union Saint-Jean
Summary
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
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.
* 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.
Source: ClinicalTrials.gov (NCT06640764). StuddyBuddy aggregates publicly available trial information.