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

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.