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
This trial does not accept healthy volunteersQualifiers
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 population
150 patients undergoing hip resurfacing surgery and receiving the ROMAX system will be recruited consecutively by the study investigator. All patients will be offered to join the CTMA subgroup until the number of 40 subjects is reached. Choosing not to participate in the CTMA subgroup will not prevent the patient from participating in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hip resurfacing system
DeviceHip resurfacing with ROMAX system
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: ROMAX1 intervention
Trial outcomes
Primary outcomes
1
Implant survival
Survival of the implant through Kaplan-Meier analysis based on revisions
Time frame
10 yearsSecondary outcomes
1
Harris Hip Score (HHS)
Measure of dysfunction ranging from 0 to 100, where higher values represent better outcomes.
Time frame
3 months, 1 year, 3 years, 5 years, 10 years2
Forgotten Joint Score (FJS)
Patient-reported outcome measure that evaluates joint dysfunction. It ranges from 0 to 100, with higher scores indicating better outcomes
Time frame
3 months, 1 year, 3 years, 5 years, 10 years3
Postel-Merle d'Aubigné Score (PMA)
Clinical rating system used to assess hip function. It ranges from 0 to 18, with higher scores indicating better hip function and fewer limitations in activities.
Time frame
3 months, 1 year, 3 years, 5 years, 10 years4
Oxford Hip Score (OHS)
Patient-reported outcome measure designed to assess hip function and pain. It ranges from 0 to 48, with higher scores indicating better function and less pain.
Time frame
3 months, 1 year, 3 years, 5 years, 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov