Multicentre SMS Study - FR

Medacta

Status: Enrolling

Conditions: Hip Osteoarthritis; Dysplasia of Hip Joint; Avascular Necrosis of Femur Head; Traumatic Arthritis of Hip

Treatments: Procedure: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT06640764

P01.019.07

Details and patient eligibility

About

Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.