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NCT Number: NCT06775704

Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

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.

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Key information

Conditions

Arthritis (Hip) Arthritis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Hip Dislocation, Congenital Hip Dysplasia, Congenital Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hip resurfacing system

Device

Hip resurfacing with ROMAX system

Primary outcomes

  1. Implant survival

    Time frame: 10 years

    Survival of the implant through Kaplan-Meier analysis based on revisions

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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).

  6. 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.

  7. Radiologic Evaluation

    Time frame: 3 months, 1 year, 3 years, 5 years, 10 years

    Assessment of implant positioning and radiographic appearence.

  8. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Viganò, PhD

CONTACT

[email protected]

+41 0916966060

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2037
Study completion
2037
First posted
Jan 15, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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