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General Orthopaedics

PROSTHETIC IMPLANT FAILURES IN AUSTRALIA THE TRUTH – THE WHOLE TRUTH

Australian Orthopaedic Association Limited (AOA)



Abstract

The advent of the Australian National Joint Replacement Registry has been an outstanding success in identifying prosthesis with higher than average failure rates, but it is principally a measure of revision rates for specific prostheses.

In order to consider the causes of failure it is necessary to start at the point where prostheses are able to enter the Australian market through the Therapeutic Goods administration, Australian Registered Therapeutic Goods list (ARTG) and consider each of the steps of the joint replacement procedure from that point to well beyond the operation date.

This ARTG listing process as it now exists is described and an explanation of how this process may need to be reformed if the occasionally very inadequate prosthesis is to be eliminated from the Australian market. Other matters that may be predictors of variable outcomes include hospital case volume, surgeon experience, patient selection and pre-operative planning.

Intra-operative factors that lead to failure, including from infection, will include surgical approaches, operative technique, instrumentation, wound care and theatre discipline.

Post operatively patient factors, particularly falls and osteoporosis, will influence long-term outcomes as will prosthesis performance.

Further concern has been the advocacy by some by what might be considered, fashionable orthopaedics, but the literature to date has demonstrated little benefit from endeavours such as minimal invasive surgery and two-incision hip replacement. Gender specific prostheses and navigation have yet to make their mark as a universally accepted method of performing joint replacement surgery and there may be some negative issues with these matters.