Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMedacta International SA
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Hip resurfacing system
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov