NCT06775704

Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

Résultats Cliniques et Radiologiques du Dispositif de resurfaçage de Hanche ROMAXTM Medacta

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Arthritis (Hip)
• Hip Dysplasia, Congenital

Interventions

Type	Name	Description
DEVICE	Hip resurfacing system	Hip resurfacing with ROMAX system

Timeline

• Start date: 2025-07-14
• Primary completion: 2037-04-01
• Completion: 2037-04-01
• First posted: 2025-01-15
• Last updated: 2025-09-25

Locations

1 site across 1 country: France