Assessing the performance of a specific hip implant in patients needing hip replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Spinal anesthesia with intrathecal morphine vs PENG block (with or without dexamethasone) for hip replacement

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.