Manufacturers and suppliers, described here as sponsors, who wish to have products approved and listed for use in Australian hospitals must follow a defined process. They must obtain an Australian Registered Therapeutic Goods number (ARTG) for the product to be used. For benefits to be paid for prostheses used under private health insurance arrangements a catalogue number is obtained after being approved through the Prosthesis Listing Advisory Committee (PLAC). Under PLAC each group of like prostheses is assessed by a Clinical Advisory group. (Hip Prosthesis Clinical Advisory Group, Knee Prosthesis Clinical Advisory Group). Existing criteria are being enhanced as to the levels of evidence required for listing approval. Essentially for joint replacements which are weight-bearing and in category three a two year clinical trial will almost always be necessary for any new prosthesis. Products must bw considered as non-inferior to comparator products.
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.
