A Clinical Investigation to evaluate safety and performance of APEX KNEE Vitamin E, Cold Gamma Irradiated, Mechanically Annealed XLPE (ECiMa) Patella and Tibial Insert components in primary Total Knee Arthroplasty in patients with knee osteoarthritis

This is a pre-market, multi-centre, non-comparative, open label prospective interventional study. The study aims to evaluate the safety and performance of APEX KNEETM ECiMa Patella and Tibial Insert components in patients undergoing primary Total Knee Arthroplasty. The Apex Knee™ System is a Class III Orthopaedic device intended for use as a primary or revision Total Knee Replacement. It is approved by the Therapeutic Goods Administration and is listed on the prostheses list. The investigational devices, the Apex KneeTM ECiMa Patella and Tibial Insert devices are a line extension to the existing Apex KneeTM System. The investigational devices are composed of Vitamin E blended highly crosslinked polyethylene, introducing a new material option to the current range. This variant has already received approval from the Food and Drug Administration (US) and obtained CE mark (Europe) but do not yet have a listing on the Australian Register of Therapeutic Goods.) hence this study will be conducted under a Clinical Trial Notification (CTN) modification. This study will be a prospective study to evaluate the clinical outcomes and survivorship of the APEX Knee™ prosthesis with the ECiMa insert and Patella In this study, the patients eligible for total knee replacement surgery will be identified by the Orthopaedic surgeon from his patient database. The patients will be given an information form to read and sign. Following the signature, the patients will be assessed for suitability for participating in the study. Once they fit the criteria, they will be enrolled in the study. After enrolment, the patients will complete some clinical assessments including measuring Range of Motion (ROM) and taking an X-ray of the knee. Medical history will be collected, and physical examination will be done. They will also complete 3 quality of life questionnaires to assess their quality of life before the surgery. The assessments before surgery will take 2-4 hours. On the day of the surgery, participants will receive APEX Knee™ system and one of three different types of ECiMa Tibial Inserts: Cruciate retaining, Ultra-Congruent, Posterior Stabilising. The choice of this insert will be determined by the Orthopaedic surgeon based on clinical need. Not all patients will necessarily receive the ECiMa patella device. Use of the patella component is at the discretion of the surgeons based on the clinical judgment. If the surgeon chooses to resurface the Patella then it will be with the ECiMa Patella device. The surgery will be completed by experienced Orthopaedic surgeons who have received training on the products and will take about 2-3 hours. Following the surgery, the patient will do another X-ray while at the hospital before discharge. Following the surgery, the patient will complete 5 follow up visits over a span of 10 years, where the safety and performance of the ECiMa Patella and Tibial Insert devices will be measured via various assessments such as physical examinations, ROM, X-Rays and quality-of-life questionnaires. Some of these visits can be completed from the Orthopaedic surgeon’s clinic and some can be completed from home, where the patient can complete the questionnaires from their smart phone or computer. Throughout the study, any adverse event that the patient may be experiencing will be reported to the orthopaedic surgeon and his study team. The follow up study visits will take approximately 1-2 hours depending on the nature of the visit. The study team will send timely reminders to the participant ahead of the follow up visit.