Recruiting NCT06640764
Multicentre SMS Study - FR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Hip Arthroplasty.
- Who it may be relevant to
- Registry conditions: Dysplasia of Hip Joint, Hip Osteoarthritis, Traumatic Arthritis of Hip, Avascular Necrosis of Femur Head. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
Overview
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
Interventions
- Procedure Total Hip Arthroplasty
Total Hip Arthroplasty with SMS Femoral Stem (Medacta)
Primary outcome measures
- Survival rate of SMS femoral stem [Time frame: From enrollment to the end of treatment at 10 years]
Secondary outcome measures (5)
- Evaluation of the clinical performance of the SMS femoral stem [Time frame: From enrollment to the end of treatment at 10 years]
- Evaluation of the hip function [Time frame: From enrollment to the end of treatment at 10 years]
- Evaluation of the quality of life [Time frame: From enrollment to the end of treatment at 10 years]
- Evaluation of the safety (adverse events) of the SMS femoral stem [Time frame: From enrollment to the end of treatment at 10 years]
- Evaluation of the stability and the fixation of the SMS femoral stem [Time frame: From enrollment to the end of treatment at 10 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Clinique de l'Union — Saint-Jean
Identifiers
NCT: NCT06640764 · P01.019.07