Arthritis (Hip)NCT06775704
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
An observational study of Arthritis (Hip) and Hip Dysplasia, Congenital, run by Medacta International SA at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthritis (Hip), Hip Dysplasia, Congenital
- What is being tested?
- Hip resurfacing system
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jul 2025to 1 Apr 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59000
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis (Hip), Hip Dysplasia, Congenital
- Being tested
- Hip resurfacing system
- Keywords
- resurfacing
- Medical subject headings
- Arthritis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip resurfacing systemDevice
Hip resurfacing with ROMAX system
| Study group | Role | What they receive |
|---|---|---|
| ROMAX | Patients undergoing hip resurfacing surgery with ROMAX system Receives: Device: Hip resurfacing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Survival of the implant through Kaplan-Meier analysis based on revisions
Measured: 10 years
Secondary outcomes (8)
Harris Hip Score (HHS)
Measure of dysfunction ranging from 0 to 100, where higher values represent better outcomes.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 months, 1 year, 3 years, 5 years, 10 years
UCLA Activity Scale
Questionnaire assessing physical activity level from 1 (low) to 10 (high).
Measured: 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.
Measured: 3 months, 1 year, 3 years, 5 years, 10 years
Radiologic Evaluation
Assessment of implant positioning and radiographic appearence.
Measured: 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)
Measured: 3 months, 1 year, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start14 Jul 2025
- Primary completion1 Apr 2037 (estimated)
- Study completion1 Apr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis (Hip)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775704
- Sponsor's protocol ID
- P 01.012.07
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Résultats Cliniques et Radiologiques du Dispositif de resurfaçage de Hanche ROMAXTM Medacta
- ClinicalTrials.gov ID
- NCT06775704
- Acronym / sponsor ID
- P 01.012.07
- Conditions
- Arthritis (Hip), Hip Dysplasia, Congenital
- Keywords
- resurfacing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 1 Apr 2037 (estimated)
- Study completion
- 1 Apr 2037 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROMAX | – | Device: Hip resurfacing systemPatients undergoing hip resurfacing surgery with ROMAX system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip resurfacing systemHip resurfacing with ROMAX system | Device | ROMAX |
Primary outcome
Implant survival
Time frame: 10 years
Survival of the implant through Kaplan-Meier analysis based on revisions
8 secondary outcomes
Harris Hip Score (HHS)
Time frame: 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
Postel-Merle d'Aubigné Score (PMA)
Time frame: 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
UCLA Activity Scale
Time frame: 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
Radiologic Evaluation
Time frame: 3 months, 1 year, 3 years, 5 years, 10 years
CT-micromotion analysis (CTMA)
Time frame: 3 months, 1 year, 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis (Hip) and Hip Dysplasia, Congenital, run by Medacta International SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Viganò, PhD (+41 0916966060, m.vigano@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.