RecruitingACTRN12622001141730

A Multi-centre, Prospective, Clinical Outcomes Study to evaluate the MPRES Stem following primary Total Hip Arthroplasty

A Multi-centre, Prospective, Clinical Outcomes Study to evaluate the MPRES Femoral Stem survivorship (efficacy) following primary Total Hip Arthroplasty


Sponsor

Medacta Australia Pty Ltd

Enrollment

280 participants

Start Date

Jun 27, 2022

Study Type

Interventional

Conditions

Summary

Traditionally, surgeons undertaking THA have performed a distal neck osteotomy, which invariably necessitated the excision of healthy bone. The introduction of bone-conserving short-stem implants has shown there is a growing body of evidence to suggest that retaining the femoral neck can provide mechanical and biological advantages. One of the aims of successful THA is to restore this environment to its native state. Following surgery, femoral components are subject to high torsional and shear forces that can precipitate implant movement. Torsional stability is known to be an important factor in implant fixation and can influence survivorship. The prostheses are also subjected to vertical forces that can produce interface micro-motion or result in migration of the stem into varus. It is argued that neck preservation offers superior tri-planar implant stability and allows more accurate restoration of the hip biomechanics. Medacta International have recently developed a new short femoral stem device designed for use in total hip arthroplasty. The femoral stem is one component of a total hip replacement. The MPRES femoral stem is not yet approved by the TGA however, Medacta International has obtained European CE Mark Approval. CE Marking allows Medacta to supply the MPRES device in the European Union (EU). The MPRES is a Neck Sparing Stem, as it is designed to be bone conserving. It has been designed as a primary uncemented femoral stem for use in total hip arthroplasty. The design intent on the MPRES stem is to provide a THA that preserves healthy bone stock and allow for minimal invasive surgical approaches. The MPRES is a cementless, biplanar, wedge-shaped monoblock stem of Titanium Alloy and hydroxyapatite coating. It is currently unknown if the new MPRES cementless femoral stem device has noninferiority revision rates in comparison to all other on-market femoral stems. The purpose of this study is to assess the safety and performance of the MPRES. This will be achieved by both assessing the survivorship data and collecting patient reported outcome measures from patients who are having the MPRES device.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new type of hip replacement implant called the MPRES stem, designed by Medacta International. Unlike traditional hip replacement stems that require removing healthy bone from the upper part of the thigh bone, this implant is a "bone-conserving" or "neck-sparing" design — meaning it tries to preserve as much of your natural bone as possible. The idea is that keeping more of your own bone in place may lead to a more stable implant and better long-term outcomes. The MPRES stem is made from titanium alloy with a special coating to help the bone grow into it naturally, without needing cement to hold it in place. It has already received approval in Europe, and this study is part of the process to evaluate its safety and performance in Australia. You may be eligible if you are aged 18 to 75, are scheduled for a primary (first-time) total hip replacement due to joint disease like arthritis, have good bone density, and a BMI of 40 or below. People who have had a previous hip replacement, active joint infections, or certain metabolic conditions would not be eligible. The study will track how well the implant performs over time and how patients feel after surgery.

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. Each participant will receive the new Medacta MPRES 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. All observational participant data will be collected into an existing electronic App (Patient Optimized Pathway) as per standard protocol. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed during the pre-operative visit and again at 6 month, 1 year, 2 years, 5 years and 10 years time points post-procedure. Each patient will use an electronic data collection phone application which they will download onto their phones and at each timepoint they will log in and complete each of the questionnaires, using their mobile phones. The questionnaires should take up to 30 minutes for the participants to complete. Adherence to the intervention will be monitored through ongoing reviews by the independent expert data safety monitoring board (DSMB). The reviews will include the assessment of the results and any adverse events from the study.


Locations(4)

The Avenue Private Hospital - Windsor

NSW,WA,VIC, Australia

Hollywood Private Hospital - Nedlands

NSW,WA,VIC, Australia

Macquarie University Hospital - Macquarie Park

NSW,WA,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

NSW,WA,VIC, Australia

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