Short-term evaluation of the TRAX in knee replacement

The TRAX CR TKR is not currently approved for clinical use in Australia and this study is being undertaken via the Clinical Trial Notification Scheme with the Therapeutic Goods Administration (TGA). The TRAX CR TKS was developed by Amplitude (Valence, France) with the support of a design group of five Australian surgeons, in order for the manufacturer to have a full range of options for the patients. It is a modular cemented Cruciate-Retaining (CR) fixed-bearing implant intended for the total replacement of the knee joint in order to reduce pain and restore knee function in comparison with preoperative status. No major differences exist between the TRAX CR system and the modern cemented total knee systems used in primary TKA in Australia. Surgeons implementing the TRAX CR system will require specific training in order to implement the system. This training will be provided by Amplitude (the manufacturer) before the study starts. The TRAX CR system would only be available to participants who are eligible and choose to enrol in this study. Patients will undergo primary total knee arthroplasty and will be followed up to 2-years post operative. Notably, 1 appointment will be required before surgery, and 2 after surgery (at 6 months and 2 years postoperatively). Each appointment will last between 30 and 45 minutes, will be conducted by the orthopedic surgeon at the private or public hospital where the investigators are appointed. Please see below a description of each evaluation: --Preoperative visit: During the preoperative visit, patients who are possible candidates for this study are screened to determine if they meet the inclusion/exclusion criteria. If the patient is a candidate, the investigator proposes participation in the study to the patient, according to GCP guidelines. Patients must sign an HREC-approved Patient Informed Consent Form prior to participating in any study-related activities. Consent must be obtained prior to surgery. Once the patient has consented, preoperative data will be collected including: demographics and medical history, Hip-Knee-Ankle (HKA) angle, Range of Motion (ROM),, Oxford Knee Society (OKS) score , EQ-5D-5L and radiographs. --Surgery: Surgical details will be collected from the operative notes and at the time of surgery. The surgery duration is expected to be consistent with total knee replacement procedures, usually taking 1 to 2 hours. --6-month visit: During the 6-month visit (+2 months/-1 month), the following evaluations will be collected: HKA, ROM, OKS, Forgotten Joint Score (FJS), EQ-5D-5L ,radiographs (only if standard of care) and any occurred adverse event since surgery. --2-year visit : During the 2-year visit (± 3 months), the following evaluations will be collected: HKA, ROM, OKS, FJS, EQ-5D-5L ,radiographs and any occurred adverse event since last visit.