None listed
Conditions
Brief summary
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, increased wear, dislocation and reduced functional movement, which lead to poorer patient outcomes. Medacta have recently developed a new acetabular cup device called the Mpact 3D Metal Monocer, designed for use in Total Hip Replacement (THA), the acetabular cup is one component of a THA. The Mpact 3D Metal Monocer device is a cementless hemispherical acetabular shell that comes pre-assembled with a ceramic bearing surface. Pre-assembly may show to have several advantages compared with traditional modular cups used for total hip replacement procedures, including allowing the use of a larger femoral head diameter which can reduce the risk of hip replacement dislocation and reduced wear rates. The Monocer cup is also manufactured with a 3D-Printed titanium alloy material on the back-side to enhance osseointegration and thereby improve implant stability in the bone. The newly designed Mpact 3D Metal Monocer cup device has recently obtained European CE Mark approval. CE Marking allows the Medacta to supply the Mpact 3D Metal MonoCer device in the European Union (EU). The Medacta Mpact 3D Metal MonoCer acetabular cup is not yet approved by the TGA. Thus, the purpose of this study is to investigate the Monocer cup efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available acetabular cups. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless cups currently in use in the Australian Market.
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 be considered for enrollment in this study. Each participant will receive the new Medacta Mpact 3D Metal MonoCer acetabular cup device together with a compatible Medacta Femoral Head and Femoral Stem prostheses, as part of routine treatment for total hip replacement procedures. These devices will be
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 enrollment in this study. Each participant will receive the new Medacta Mpact 3D Metal MonoCer acetabular cup device together with a compatible Medacta Femoral Head and Femoral Stem prostheses, 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 and all observational participant data will be collected into the AOANJRR registry as per standard protocols. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed by the AOANJRR 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 receive SMS/email reminders at each time to log into an online portal and complete each of the questionnaires, at the participant's home using an electronic device of their choice.
Sponsors
Medacta Australia Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Patients undergoing a primary total conventional hip replacement and are suitable for a cementless acetabular cup according to the indications for use (On-label use). - Use of the non TGA approved (pre-market) Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis. - Adults aged between 18 and 75 years at the time of registration. - Ability to give informed consent. - Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Exclusion criteria
- Rheumatoid arthritis. - Patients with a history of active infection. - Any case not described in the inclusion criteria. - Revision procedures.
Outcome results
None listed