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Recruiting NCT06775704

Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

— Observational Arthritis (Hip) Hip Dysplasia, Congenital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hip resurfacing system.
Who it may be relevant to
Registry conditions: Arthritis (Hip), Hip Dysplasia, Congenital. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Hip resurfacing system
    Hip resurfacing with ROMAX system

Primary outcome measures

  • Implant survival [Time frame: 10 years]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre Hospitalier Universitaire de Lille — Lille

Identifiers

NCT: NCT06775704 · P 01.012.07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗