| NCT ID | NCT06640764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Dysplasia of Hip Joint |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2034-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2024-09-01 with a primary completion date of 2034-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06640764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Dysplasia of Hip Joint. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06640764 currently recruiting?
Yes, NCT06640764 is actively recruiting participants. Contact the research team at paul.maisongrosse@hotmail.fr for enrollment information.
Where is the NCT06640764 trial being conducted?
This trial is being conducted at Saint-Jean, France.
Who is sponsoring the NCT06640764 clinical trial?
NCT06640764 is sponsored by Medacta International SA. The trial plans to enroll 260 participants.