Clinical Trials in France / NCT06775704
Recruiting
Observational
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
NCT06775704 · tracked via the Priya Life Science France tracker
Condition(s) studied
Arthritis (Hip)Hip Dysplasia, Congenital
Investigational drug(s) / intervention(s)
Hip resurfacing system
Hip resurfacing system: Hip resurfacing with ROMAX system
Study summary
The goal of this observational study is to collect clinical and radiological data to monitor the safety and performance of the ROMAX hip resurfacing system. The main parameter that will be measured is the rate of revisions at 10 years.
Eligibility
Inclusion Criteria:
* Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use.
* Aged between 18 and 65 years at the time of surgery.
* Ability and willingness to provide written informed consent for participation.
Exclusion Criteria:
* Active infection
* BMI \> 40
* Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams.
* Significantly deformed anatomy (at the surgeon's discretion)
* Osteomalacia where the fixation of an uncemented implant is contraindicated
* Active rheumatoid arthritis
* Osteoporosis
* Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated
* Muscle atrophy or neuromuscular disease
* Known allergy or hypersensitivity to the implant material
* Any patient who cannot or does not wish to give informed consent to participate in the study
* Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.
Primary outcome measure(s)
- Implant survival — 10 years
Survival of the implant through Kaplan-Meier analysis based on revisions
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Lille | Lille | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06775704 on ClinicalTrials.gov ↗ ← All trials in France