RecruitingNCT06775704

Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

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

Sponsor

Medacta International SA

Enrollment

150 participants

Start Date

Jul 14, 2025

Study Type

OBSERVATIONAL

Conditions

Hip Dysplasia, Congenital Arthritis Hip

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 Criteria12

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.