Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

NCT06775704 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-07-14
Last updated
2026-10-07

Condition(s) studied

Arthritis (Hip)Hip Dysplasia, Congenital

Investigational drug(s) / intervention(s)

Hip resurfacing system

Hip resurfacing system: Hip resurfacing with ROMAX system

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use. * Aged between 18 and 65 years at the time of surgery. * Ability and willingness to provide written informed consent for participation. Exclusion Criteria: * Active infection * BMI \> 40 * Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams. * Significantly deformed anatomy (at the surgeon's discretion) * Osteomalacia where the fixation of an uncemented implant is contraindicated * Active rheumatoid arthritis * Osteoporosis * Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated * Muscle atrophy or neuromuscular disease * Known allergy or hypersensitivity to the implant material * Any patient who cannot or does not wish to give informed consent to participate in the study * Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.

Primary outcome measure(s)

  • Implant survival — 10 years
    Survival of the implant through Kaplan-Meier analysis based on revisions

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Universitaire de Lille Lille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06775704 on ClinicalTrials.gov ↗ ← All trials in France