Assessing the performance of a specific hip implant in patients needing hip replacement
Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
This study tests how well a new hip implant works for people with severe hip pain who need a hip replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Saint-Jean) |
| Trial ID | NCT06640764 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance and stability of the Medacta SMS femoral stem in patients suffering from severe hip joint pain due to conditions like osteoarthritis and avascular necrosis. It involves multiple centers and focuses on patients who require total hip arthroplasty. Participants will be monitored for their outcomes following the implantation of the femoral stem, providing valuable data on its effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with severe hip joint pain requiring total hip replacement due to specific conditions.
Not a fit: Patients with acute infections, significant anatomical deformities, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing hip replacement surgery.
How similar studies have performed: While this study is focused on a specific implant, similar observational studies have shown promising results in evaluating hip replacement technologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint-Jean
- Clinique de l'Union — Saint-Jean, France (Recruiting)
Study contacts
- Study coordinator: Paul Maisongrosse
- Email: paul.maisongrosse@hotmail.fr
- Phone: 0033 05 61 37 85 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.