Actively Recruiting
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System Medacta
Led by Medacta International SA · Updated on 2025-09-25
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Medacta ROMAX hip resurfacing system in patients with hip arthritis or congenital hip dysplasia. This observational study aims to track the implant's survival rate over 10 years, focusing on dislocations and wear-related effects. The trial also assesses patient-reported outcomes and the migration behavior of the device using a specialized CTMA method in a subgroup of patients. The study includes 150 patients undergoing hip resurfacing surgery with the ROMAX system. A subgroup of 40 patients will have additional CTMA analysis at 3 years after surgery. Follow-up visits are scheduled at 3 months, and then at 1, 3, 5, and 10 years post-surgery. Data collected includes clinical scores, radiological and clinical assessments before and after surgery, and details about the surgical procedure. Participants will be evaluated through clinical and radiological exams, as well as questionnaires measuring hip function and activity levels at multiple time points up to 10 years. For the CTMA subgroup, detailed imaging will assess implant migration at 3 months, 1 year, and 3 years. The primary outcome measured is implant survival at 10 years, with several secondary outcomes including various hip function scores and radiologic evaluations. The study monitors participant progress and safety during the entire follow-up period.
CONDITIONS
Brief 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
- Aged between 18 and 65 years at the 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 likely to compromise consent, progress assessment, or follow-up
- Significantly deformed anatomy as judged by the 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 give informed consent
- Medical conditions that would compromise regaining independent mobility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during preoperative assessments
Duration - Day of surgery and hospital stay until discharge
Participants undergo hip resurfacing surgery using the ROMAX system and receive immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 10 years
Participants have clinical and radiological evaluations to assess recovery and implant status.
Visits at 3 months, 1 year, 3 years, 5 years, and 10 years
Duration - 10 years
Participants are monitored for implant survival, clinical performance, and possible complications over a 10-year period.
Regular assessments included in follow-up visits
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire de Lille
Lille, France, 59000
Actively Recruiting
Research Team
M
Marco Viganò, PhD
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here