ROMAX hip resurfacing: expected clinical and radiological outcomes over 10 years
Résultats Cliniques et Radiologiques du Dispositif de resurfaçage de Hanche ROMAXTM Medacta
This project will test how well the ROMAX hip resurfacing implant works and how safe it is over 10 years in adults aged 18–65 who receive hip resurfacing for arthritis or congenital hip problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Lille) |
| Trial ID | NCT06775704 on ClinicalTrials.gov |
What this trial studies
This is a single-center, post-market, prospective, longitudinal cohort following 150 hip resurfacing cases to monitor device survival and safety over 10 years. The primary outcome is the 10-year revision rate, with additional collection of clinical scores, patient-reported outcomes, radiological data, and perioperative details. A voluntary subgroup of 40 patients will undergo CT-based migration analysis (CTMA) at 3 years to study implant movement. Follow-up visits are scheduled at 3 months, 1, 3, 5, and 10 years to track outcomes and adverse events.
Who should consider this trial
Good fit: Adults aged 18–65 who are eligible for hip resurfacing according to the manufacturer's indications, who can give informed consent and commit to scheduled long-term follow-up, are ideal candidates.
Not a fit: Patients with active infection, BMI over 40, osteoporosis, metabolic bone disorders, active rheumatoid arthritis, significant deformity, neuromuscular disease, or known allergy to implant materials are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the study could provide 10-year device-specific evidence of implant survival and functional outcomes to help patients and surgeons make informed choices.
How similar studies have performed: Previous hip resurfacing devices have produced mixed results—some systems show durable outcomes in carefully selected patients while others have had high revision rates—so device-specific long-term data are important.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lille
- Centre Hospitalier Universitaire de Lille — Lille, France (Recruiting)
Study contacts
- Study coordinator: Marco Viganò, PhD
- Email: m.vigano@medacta.ch
- Phone: +41 0916966060
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.