Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

NCT06775704 | Recruiting

• 1 other identifier: P 01.012.07
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis (Hip); Hip Dysplasia, Congenital

Keywords

resurfacing

Outcome Measures

Primary Outcomes (1)

• Implant survival

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

  10 years

Secondary Outcomes (8)

• Harris Hip Score (HHS)

  3 months, 1 year, 3 years, 5 years, 10 years

• Forgotten Joint Score (FJS)

  3 months, 1 year, 3 years, 5 years, 10 years

• Postel-Merle d'Aubigné Score (PMA)

  3 months, 1 year, 3 years, 5 years, 10 years

• Oxford Hip Score (OHS)

  3 months, 1 year, 3 years, 5 years, 10 years

• UCLA Activity Scale

  3 months, 1 year, 3 years, 5 years, 10 years

Study Arms (1)

ROMAX

Patients undergoing hip resurfacing surgery with ROMAX system

Device: Hip resurfacing system

Interventions

Hip resurfacing system DEVICE

Hip resurfacing with ROMAX system

ROMAX

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Arthritis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Marco Viganò, PhD

CONTACT

+41 0916966060; m.vigano@medacta.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): April 1, 2037
• Study Completion (Estimated): April 1, 2037
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)