Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Dysplasia, Congenital; Arthritis (Hip)
• Intervention / Treatment: Device: Hip resurfacing system

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Marco Viganò, PhD; Phone Number: +41 0916966060; Email: m.vigano@medacta.ch

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Centre Hospitalier Universitaire De Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

150 patients undergoing hip resurfacing surgery and receiving the ROMAX system will be recruited consecutively by the study investigator. All patients will be offered to join the CTMA subgroup until the number of 40 subjects is reached. Choosing not to participate in the CTMA subgroup will not prevent the patient from participating in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ROMAX; Patients undergoing hip resurfacing surgery with ROMAX system	Device: Hip resurfacing system; Hip resurfacing with ROMAX system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	Survival of the implant through Kaplan-Meier analysis based on revisions	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS)	Measure of dysfunction ranging from 0 to 100, where higher values represent better outcomes.	3 months, 1 year, 3 years, 5 years, 10 years
Forgotten Joint Score (FJS)	Patient-reported outcome measure that evaluates joint dysfunction. It ranges from 0 to 100, with higher scores indicating better outcomes	3 months, 1 year, 3 years, 5 years, 10 years
Postel-Merle d'Aubigné Score (PMA)	Clinical rating system used to assess hip function. It ranges from 0 to 18, with higher scores indicating better hip function and fewer limitations in activities.	3 months, 1 year, 3 years, 5 years, 10 years
Oxford Hip Score (OHS)	Patient-reported outcome measure designed to assess hip function and pain. It ranges from 0 to 48, with higher scores indicating better function and less pain.	3 months, 1 year, 3 years, 5 years, 10 years
UCLA Activity Scale	Questionnaire assessing physical activity level from 1 (low) to 10 (high).	3 months, 1 year, 3 years, 5 years, 10 years
HOOS (Hip injury and Osteoarthritis Outcome Score) Symptoms subscale	Patient-reported outcome measure comprising 5 questions assessing hip joint symptoms and stiffness. It ranges from 0 to 100, with higher values indicating better outcomes.	3 months, 1 year, 3 years, 5 years, 10 years
Radiologic Evaluation	Assessment of implant positioning and radiographic appearence.	3 months, 1 year, 3 years, 5 years, 10 years
CT-micromotion analysis (CTMA)	CT-based evaluation of implant movement and wear. Will be performed on a subgroup of patients (40)	3 months, 1 year, 3 years

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): April 1, 2037
• Study Completion (Estimated): April 1, 2037

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: resurfacing
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Developmental Dysplasia of the Hip; Arthritis; Hip Dislocation, Congenital
• Other Study ID Numbers: P 01.012.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No