A post-market clinical investigation to evaluate clinical and patient-reported outcomes following a total hip arthroplasty surgery with Trinity™ Dual Mobility System.

This is a post-market, multi-centre, non-comparative, open label prospective interventional study. The study aims to measure the performance and the safety of Trinity™ Dual Mobility System in patients undergoing Hip Replacement Surgery. It will also measure the whole blood metal ions (Cobalt, Chromium and Titanium) levels in these patients receiving the TrinityTM Dual Mobility System at a minimum 2-year follow-up following the surgery. In this study the eligible patients who will undergo hip replacement surgery will be identified by the Orthopaedic surgeon from his patient database. The patients will be a 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 assessments and a X Ray. Medical History will be collected and physical health assessment will be done. They will also complete 3 quality-of-life questionnaires to assess their quality of life before the surgery. Those patients who will be participating in the blood subgroup analysis will be giving a blood sample. The assessments before surgery will take approximately 2-4 hours. On the day of the surgery the participants will receive the following components for the hip surgery - TrinityTM Dual Mobility System in combination with a Corin Femoral Stem. The Trinity™ Dual Mobility System is not ‘new’ and is a commonly used hip prosthesis in Australia. It has been approved for use by the Australian Therapeutic Goods Administration since 2017 and over 1800 procedures have been performed using the Trinity™ Dual Mobility in Australia. The surgery will be completed by the Orthopaedic surgeons and will take about 2 hours. Following the surgery the patient will do another X Ray while at the hospital before discharge. Following the surgery, the patient will complete a few follow up visits over a span of 5 years where the safety and performance of the Trinity DM cup will be measured by various assessments like blood tests, X Ray, physical exams and the quality-of-life questionnaires. Some of these follow up visits will be completed at the Orthoapedic surgeon’s office and some of these visits can be completed from home where the patients will be completing the questionnaires on 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.