Joe Ludwig (Queensland, Australian Labor Party, Manager of Government Business in the Senate) Share this | Link to this | Hansard source

Senator Xenophon asked me about artificial joint replacements on 18 November. I seek leave to incorporate an answer in Hansard.

Leave granted.

The answer read as follows—

Question without Notice—additional information to question asked by Senator Xenophon, 18 November 2009

Artificial Joint Replacement

My question is to Senator Ludwig, Minister representing the Minister for Health, Minister Roxon and relates to artificial joint replacement.

In the Australian newspaper on 25th August this year, Minister Roxon is reported to have said that:

“99 per cent of patients are provided joints that are less dependable and often more expensive that the most reliable one.

I ask the Minister, is it accurate that in Australia the best prothesis is only used in one percent of joint artificial joint replacements?

Answer: The comments made by the Minister were drawn from information published in the 2008 Australian Orthopaedic Association Annual Report of the National Joint Replacement Registry Hip and Knee Arthroplasty. The NJRR’s findings about the hip femoral stems and acetabular cup combinations with the lowest revision rates are at pages 55-56 of the report. The report also includes information on the total number of surgeries, and numbers involving particular components and component combinations. The report is available at:

http://www.dmac.adelaide.edu.au/aoanirrinublicationsjsp?section=renorts2008

It should be noted that the Minister’s speech included advice that devices identified by the NJRR as having the lowest revision rates were not necessarily appropriate for all patients requiring joint replacement surgery.

Supplementary:

Mr President, I ask a supplementary question.

The National Joint Replacement Registry was established in 1998 and earlier this year a levy was introduced to support its work.

• Does this Registry record how many of the new joint replacement products approved in the last four years have performed better in relation to rates of revision than the products previously available?

Answer: Yes, in relation to some components and surgeries. The Registry records and publishes information on the outcome of joint replacement surgery in Australia, including comparative revision rates observed with different components used in surgeries. The most recent publication of the NJRR on hip and knee replacement surgeries is the 2009 Australian Orthopaedic Association Annual Report of the National Joint Replacement Registry Hip and Knee Arthroplasty, which was published in October 2009 and is available at: http://www.dmac.adelaide.edu.au/aoaninipublications.isp7section=reports2009. This report includes information about the outcomes of hip and knee replacement surgeries between 1999 and 31 December 2008.

The Registry is now also recording information about the outcomes of other types of joint replacement surgeries, including shoulder, elbow, wrist, ankle and spinal disc arthroplasty, but only some of this data would be available prior to 2007. Most hospitals began providing data on these additional arthroplasty procedures on or after the official commencement date of 15 November 2007. The Registry did collect data about these additional arthroplasty procedures from a number of hospitals prior to the commencement date, so there is some data from 16 April 2004. The reports on other types of joint replacement surgeries, including Demographics of Shoulder, Elbow, Wrist, Ankle and Spinal Disc Arthroplasty (published October 2009) and Analysis of State and Territory Health Data—All Arthroplasty (published November 2009), are also available at the above website address.

• If so, how many joints were approved and what proportion performed better?

The number of total joint implants approved by Therapeutic Goods Administration in the last 4 years is:

Hips —36

Knees —38

Shoulders —16

Information about revision rates recorded by the National Joint Replacement Registry associated with all components used in joint replacement surgeries is available from the published reports on the Registry’s website.

Supplementary:

Mr President, I ask a further supplementary question.

• Can the Minister inform the Senate how many of these new joint replacements underwent two years clinical trial prior to being approved for use in Australia?

The Australian regulatory system for medical devices is based on an internationally harmonised approach to medical device regulation. The framework adopts a risk-based approach which balances regulatory oversight with provision of timely access to new technology for Australian users.

Prior to marketing, manufacturers are required to demonstrate the device is compliant with standards (referred to as Essential Principles) for safety and performance, including provision of appropriate clinical evidence, such as performance under clinical trial or international post-market surveillance data. The Australian regulatory system allows for recognition of overseas reviews of this evidence when conducted by a recognised agency with similar regulatory controls to those employed in Australia.