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.
This single-center, post-market, prospective, longitudinal, and uncontrolled cohort study aims to evaluate the survival rate of the Medacta ROMAX hip resurfacing system, particularly focusing on dislocations and the potential consequences of wear over a 10-year period. Additionally, the study will assess clinical performance through patient-reported outcomes (PROMs) and analyze the migration behavior of the device using the CTMA method in a subgroup of 40 patients. The study will include a total of 150 cases, with 40 patients undergoing CTMA analysis at 3 years post-surgery. Eligible patients will be informed during preoperative visits and included upon signing the consent form, prior to surgery. Participation in the CTMA subgroup is optional and does not affect overall study inclusion. Follow-ups will be conducted at 3 months, 1, 3, 5, and 10 years. Data collection will include clinical scores, clinical and radiological data related to preoperative and postoperative status, and perioperative surgical details.
Study Type
OBSERVATIONAL
Enrollment
150
Hip resurfacing with ROMAX system
Centre Hospitalier Universitaire de Lille
Lille, France
RECRUITINGImplant survival
Survival of the implant through Kaplan-Meier analysis based on revisions
Time frame: 10 years
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 years
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 years
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 years
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 years
UCLA Activity Scale
Questionnaire assessing physical activity level from 1 (low) to 10 (high).
Time frame: 3 months, 1 year, 3 years, 5 years, 10 years
HOOS (Hip injury and Osteoarthritis Outcome Score) Symptoms subscale
Patient-reported outcome measure comprising 5 questions assessing hip joint symptoms and stiffness. It ranges from 0 to 100, with higher values indicating better outcomes.
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Time frame: 3 months, 1 year, 3 years, 5 years, 10 years
Radiologic Evaluation
Assessment of implant positioning and radiographic appearence.
Time frame: 3 months, 1 year, 3 years, 5 years, 10 years
CT-micromotion analysis (CTMA)
CT-based evaluation of implant movement and wear. Will be performed on a subgroup of patients (40)
Time frame: 3 months, 1 year, 3 years