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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROMAX | Patients undergoing hip resurfacing surgery with ROMAX system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip resurfacing system | Device | Hip resurfacing with ROMAX system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival | Survival of the implant through Kaplan-Meier analysis based on revisions | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | Measure of dysfunction ranging from 0 to 100, where higher values represent better outcomes. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Viganò, PhD | Contact | +41 0916966060 | m.vigano@medacta.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D006618 | Hip Dislocation, Congenital |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
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| 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. | 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. | 3 months, 1 year, 3 years, 5 years, 10 years |
| UCLA Activity Scale | Questionnaire assessing physical activity level from 1 (low) to 10 (high). | 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. | 3 months, 1 year, 3 years, 5 years, 10 years |
| Radiologic Evaluation | Assessment of implant positioning and radiographic appearence. | 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) | 3 months, 1 year, 3 years |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |