RecruitingACTRN12625000233426

A multi-centre, prospective study to evaluate the M-Finity femoral Stem in patients undergoing Total Hip Arthroplasty

Sponsor

Medacta Australia Pty Ltd

Enrollment

280 participants

Start Date

Aug 5, 2025

Study Type

Interventional

Conditions

Degenerative Osteoarthritis Total Hip Arthroplasty

Summary

This study will evaluate the safety and clinical effectiveness of the M-Finity femoral stem used in total hip arthroplasty. This will be achieved by assessing survivorship and collecting patient reported outcome measures from patients receiving the M-Finity stem. Patient clinical and radiographic outcomes will be analysed pre-implantation and post-implantation through to 2 years and clinical outcomes continued to 10 years. The survivorship data will be compared to the cementless stems currently on the market using the Australian Orthopaedic Association National Joint Registry (AOANJRR) data. The hypothesis is that the 2-year cumulative percent revision of the M-Finity cementless femoral stem is not inferior to the performance of other femoral stems currently on the Australian market.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Hip replacement surgery (total hip arthroplasty) is one of the most common and successful operations performed today, offering life-changing relief from hip pain and disability. The femoral stem is the metal component inserted into the thigh bone during the operation. The M-Finity is a new design of femoral stem that aims to preserve more of the natural bone at the top of the femur. This multi-centre Australian study is evaluating the safety and clinical effectiveness of the M-Finity femoral stem over 10 years. Researchers will track survival of the implant (how often it needs to be revised or replaced), patient-reported outcomes (pain, function, quality of life), and X-ray findings. Results will be compared against national registry data for other femoral stems currently on the market. You may be eligible if you are 18 or older, need a primary (first-time) total hip replacement, have a BMI of 40 or under, and are suitable for a cementless femoral stem. People with previous hip surgery on the same side, active joint infection, or severe bone density problems are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrolment in this study. The M-Finity femoral stem is an implant designed for THA. The implant is designed to provide a good fit and stability. Each participant will receive the new Medacta M-Finity femoral stem device together with a compatible Medacta Acetabular Cup, as part of routine treatment for total hip replacement procedures. These devices will be implanted by qualified and experienced orthopaedic surgeons as per routine practice. The duration of the procedure will take approximately 1-1.5 hours, as per a standard THA. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed during the pre-operative visit and again at 3 months, 1 year, 2 years, 5 years and 10 years time points post-procedure. Routine x-rays will be analysed at 3 months, 1 year, 2 years, 5 years and 10 years timepoints post-procedure to investigate the radiological performance of the implant in terms of implant placement.