RecruitingACTRN12625000948493

Evaluating the Safety and Efficacy of the ROMAX Resurfacing System in patients undergoing hip resurfacing.

Evaluating the Safety and Efficacy of the ROMAX Resurfacing System in patients undergoing hip resurfacing

Sponsor

Medacta Australia Pty Ltd

Enrollment

280 participants

Start Date

Nov 17, 2025

Study Type

Interventional

Conditions

Congenital or Developmental disorders Hip Resurfacing Degenerative Joint Disease

Summary

This study will evaluate the safety and clinical effectiveness of the ROMAX Resurfacing System in primary hip resurfacing. This will be achieved by assessing survivorship and collecting patient reported outcome measures from patients receiving the ROMAX resurfacing system. Patient clinical and radiographic outcomes will be analysed pre-implantation and post-implantation through to 3 years. The hypothesis is that the 2-year cumulative percent revision of the ROMAX resurfacing system is not inferior to the performance of other resurfacing systems currently on the Australian market.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Hip resurfacing is an alternative to total hip replacement that preserves more of the patient's own bone. Rather than replacing the entire hip joint, the surgeon caps the femoral head (ball of the hip) with a metal component. This approach is particularly popular with younger, more active patients because it can be revised to a total hip replacement later if needed. This study evaluates the ROMAX Resurfacing System from Medacta, testing how well it performs clinically over a three-year follow-up period. Participants who receive the ROMAX device as part of their planned hip resurfacing surgery will be followed up with questionnaires about pain, function, and quality of life, as well as X-rays to check the implant's positioning. Researchers will track whether any revisions (repeat surgeries) are needed and compare this rate to other resurfacing systems on the Australian market. You may be eligible if you are a skeletally mature adult (18 or over), scheduled for primary (first-time) hip resurfacing for non-inflammatory joint disease, and are not severely obese (BMI under 40). People with previous hip surgery on the affected side, active joint infection, osteoporosis, metabolic bone disorders, severe anatomical abnormalities, or known allergy to the implant materials would not be eligible.

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Interventions

Patients with degenerative hip diseases may be candidates for either a total hip replacement or a hip resurfacing surgical intervention. In comparison to a total hip replacement, where the femoral head is removed and replaced by an implant, hip resurfacing preserves the femoral head of the patient. As a result of minimising the resection of the patient’s bone, hip resurfacing is associated with a greater preservation of the bone mineral density of the femur. The ROMAX Resurfacing System is a hip resurfacing system that is designed to be utilised during a resurfacing procedure of the hip. A hip resurfacing procedure takes approximately 1.5 hours to 3 hours and the device is administered/implanted by an orthopaedic surgeon. The electornic medical records and study related documents will be assessed to monitor the adherence to the intervention. The ROMAX resurfacing system is not yet approved by the Therapeutic Goods Administration (TGA). However, it has received a class III CE mark in 2021. The implant is designed to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. The acetabular component is designed for a cementless implantation, thereby having a highly porous titanium coating for increased fixation to the bone. The acetabular component is also made up of a thin shell, allowing for a bone preserving design with adequate stiffness. The acetabular is lined with a vitamin E crosslinked ultra-high-molecular-weight polyethylene (UHMWPE) liner to prevent metal-on-metal bearing to reduce the risk of metal ion release. The femoral resurfacing head is designed for a cemented fixation on the prepared native femoral head.