Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-14

Study Completion Date

2037-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Revision LR Femoral Stem for Hip Replacement

NCT05810584

Hip Arthropathy Orthopedic Disorder

COMPLETED

Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning

NCT06272422

Coxarthrosis

NOT_YET_RECRUITING

Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

NCT05227924

Degenerative Hip Joint Disease Post-traumatic Osteoarthritis Hip Arthritis +3 more

RECRUITING

PMCF 8 Year Results TRJ®

NCT04542174

Arthroplasty, Replacement, Hip Follow-Up Study

COMPLETED

The Medacta Quadra-P Anteverted Study

NCT05460715

Arthrosis Traumatic Arthritis Rheumatoid Polyarthritis +2 more

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis (Hip) Hip Dysplasia, Congenital

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ROMAX

Patients undergoing hip resurfacing surgery with ROMAX system

Hip resurfacing system

Intervention Type DEVICE

Hip resurfacing with ROMAX system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hip resurfacing system

Hip resurfacing with ROMAX system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No