ROMAX hip resurfacing: expected clinical and radiological outcomes over 10 years

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Universitaire de Lille
  Lille, France Recruiting

Study contacts

• Study coordinator: Marco Viganò, PhD
• Email: m.vigano@medacta.ch
• Phone: +41 0916966060

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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.