Clinical trial NCT06640764: Multicentre SMS Study - FR
Official title: Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dysplasia of Hip Joint
Hip Osteoarthritis
Traumatic Arthritis of Hip
Avascular Necrosis of Femur Head
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from a severely painful and/or disabling hip joint (osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, avascular necrosis of the femoral head) requiring a total hip prosthesis and who will receive a Medacta SMS femoral stem.

Patients will be able to participate in other non-interventional research for the duration of the study.

Brief 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.

Primary outcomes:
measure: Survival rate of SMS femoral stem
timeFrame: From enrollment to the end of treatment at 10 years
Secondary outcomes:
measure: Evaluation of the clinical performance of the SMS femoral stem
timeFrame: From enrollment to the end of treatment at 10 years
measure: Evaluation of the hip function
timeFrame: From enrollment to the end of treatment at 10 years
measure: Evaluation of the quality of life
timeFrame: From enrollment to the end of treatment at 10 years
measure: Evaluation of the safety (adverse events) of the SMS femoral stem
timeFrame: From enrollment to the end of treatment at 10 years
measure: Evaluation of the stability and the fixation of the SMS femoral stem
timeFrame: From enrollment to the end of treatment at 10 years
Other outcomes:
Locations:
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
References: