NCT06775704 Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
| NCT ID | NCT06775704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Arthritis (Hip) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2037-04-01 |
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 150 participants in total. It began in 2025-07-14 with a primary completion date of 2037-04-01.
⚠ 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
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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06775704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Arthritis (Hip). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06775704 currently recruiting?
Yes, NCT06775704 is actively recruiting participants. Contact the research team at m.vigano@medacta.ch for enrollment information.
Where is the NCT06775704 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT06775704 clinical trial?
NCT06775704 is sponsored by Medacta International SA. The trial plans to enroll 150 participants.