Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

September 22, 2025 updated by: Medacta International SA

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: 10 years
Survival of the implant through Kaplan-Meier analysis based on revisions
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Harris Hip Score (HHS)
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
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)
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
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)
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
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)
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
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
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
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
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
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
Time Frame: 3 months, 1 year, 3 years, 5 years, 10 years
Assessment of implant positioning and radiographic appearence.
3 months, 1 year, 3 years, 5 years, 10 years
CT-micromotion analysis (CTMA)
Time Frame: 3 months, 1 year, 3 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2037

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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