Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

Recruiting now

Conditions studied: Arthritis (Hip), Hip Dysplasia, Congenital

In brief

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.

Key facts

Study ID

NCT06775704

Run by

Medacta International SA

People needed

150

Starts

2025-07-14

Expected to finish

2037-04-01

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Centre Hospitalier Universitaire de Lille — Lille, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.