Multicentre SMS Study - FR

Launched by MEDACTA INTERNATIONAL SA · Oct 11, 2024

Keywords

ClinConnect Summary

The Multicentre SMS Study is a clinical trial that aims to evaluate how well a specific type of hip implant, called the Medacta SMS femoral stem, works for patients with painful hip conditions. These conditions include severe hip arthritis, hip joint dysplasia, and avascular necrosis (a condition where the blood supply to the hip bone is reduced). The study is currently recruiting participants who are between 18 and 75 years old and are planning to have total hip replacement surgery due to their hip pain and disability.

To be eligible for the study, participants must be experiencing significant discomfort from their hip issues and agree to use the Medacta SMS femoral stem implant. They also need to be willing to follow the study guidelines and have signed a consent form. This study will help researchers understand the performance and stability of this implant over time. If you or someone you know meets these criteria, participating in this trial may provide valuable information for future hip replacement patients.

Gender

ALL

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.