Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

Medacta

Status

Enrolling

Conditions

Arthritis (Hip)

Hip Dysplasia, Congenital

Treatments

Device: Hip resurfacing system

Study type

Observational

Funder types

Industry

Identifiers

NCT06775704

P 01.012.07

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.