Actively Recruiting
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
Led by Medacta International SA · Updated on 2025-09-25
150
Participants Needed
1
Research Sites
611 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible for hip resurfacing and suitable for the Medacta ROMAX hip resurfacing system as per manufacturer's indication
- Aged between 18 and 65 years at time of surgery
- Ability and willingness to provide written informed consent for participation
You will not qualify if you...
- Active infection
- Body mass index (BMI) greater than 40
- Mental illness affecting ability to consent or complete follow-up
- Significantly deformed anatomy as determined by surgeon
- Osteomalacia contraindicating uncemented implant fixation
- Active rheumatoid arthritis
- Osteoporosis
- Metabolic disorders impairing bone formation contraindicating uncemented implant fixation
- Muscle atrophy or neuromuscular disease
- Known allergy or hypersensitivity to implant material
- Inability or unwillingness to provide informed consent
- Medical issues compromising chances of regaining independent mobility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire de Lille
Lille, France, 59000
Actively Recruiting
Research Team
M
Marco Viganò, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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