Clinical, radiographic and patient-reported outcomes using MobiliT™ cup with ECiMa™ insert in primary total hip arthroplasty surgery.

This Post-Market Clinical Follow (PMCF) study will evaluate clinical performance and safety outcomes of primary total hip arthroplasty surgeries using MobiliT™ ECiMa cup and Paragon™ stem over a ten-year period. Participants will be selected for recruitment into the study from the general population of patients requiring a dual mobility total hip arthroplasty surgery and considered suitable to be implanted with MobiliT™ cup and Paragon™ stem (Corin Ltd). After the surgery, participants will be required to return for follow up visits and radiographic controls at specific timepoints and complete questionnaires for a period of 10 years. The MobiliT™ ECiMa is a monobloc dual mobility system that includes a metal shell combined with a size specific polyethylene insert. This system offers two articulating surfaces in the same joint space, one between the shell and the insert, the other between the insert and the femoral head. The shell is made of stainless steel and articulates with either an Ultra High Molecular Weight Polyethylene (UHMWPE) or HXLPE (Highly Cross Linked Polyethylene) with Vitamin E (ECiMa™) polyethylene insert. Only the ECiMa insert is available in the Australian market and will be assessed in combination with the cementless MobiliT™ cup in this Post Market Clinical Follow Up (PMCF) study. This prospective PMCF study is being initiated to collect performance and functional results of dual mobility procedures performed in primary THA surgery using the MobiliT cup and the ECiMa (highly crosslinked UHMWPE with Vitamin E. All the devices used in this study are approved by the Therapeutic Goods Administration and is listed on the prostheses list. In this study, the patients eligible for total hip 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 Harris Hip Score and taking an X-ray of the hip. 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 MobiliT™ cup with either Paragon™ or Taperfit stem. The choice of the stem will be determined by the Orthopaedic surgeon based on clinical need. 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 6 follow up visits and 2 telephone visits over a span of 10 years, where the safety and performance of the MobiliT™ cup will be measured via various assessments such as physical examinations, 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.