October 1, 2013—Today, the Therapeutics Goods Administration (TGA) published their assessment of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) report.
This data will be extremely important to orthopedic companies as a recent source of post-market surveillance for their products and competitors, and development of Post-Market Clinical Follow-up (PMCF) study protocols.
You can download the most recent annual report, and the thirteen supplemental reports, from the following website: (http://bit.ly/AOA2013Reports). As you can see from the list below, this release is more extensive than previous annual reports that did not include the supplementary reports. This should be especially important for spinal companies that will be reclassifying (http://bit.ly/gapanalysiscmda) their CE Marked products from Class IIb to Class III and submitting a Design Dossier in 2014/2015.
2013 Annual Report
- Hip & Knee Arthroplasty (September 1999 to December 2012) – 213 pages
2013 Supplementary Reports
- Analysis of State and Territory Health Data All Arthroplasty – 19 pages
- Cement in Hip & Knee Arthroplasty – 15 pages
- Demographics and Outcomes of Elbow & Wrist Arthroplasty – 32 pages
- Demographics and Outcome of Ankle Arthroplasty – 11 pages
- Demographics and Outcomes of Shoulder Arthroplasty – 65 pages
- Demographics of Hip Arthroplasty – 28 pages
- Demographics of Knee Arthroplasty – 23 pages
- Demographics of Spinal Disc Arthroplasty – 11 pages
- Lay Summary 2013 Annual Report Hip and Knee Replacement – 13 pages
- Metal on Metal Total Conventional Hip Arthroplasty – 13 pages
- Mortality following Primary Hip and Knee Replacement – 10 pages
- Revision of Hip & Knee Arthroplasty – 21 pages
- Unispacer Knee Arthroplasty – 6 pages
Post-Market Clinical Data
The requirement to conduct PMCF studies is not new. Release of MEDDEV 2.12/2 rev 2 (http://bit.ly/PMCFMEDDEV) in 2012 increased the orthopedic industry’s awareness of this tool’s purpose and importance. In Europe, Notified Bodies are required to verify that manufacturers have included a PMCF protocol as part of the Post-Market Surveillance (PMS) plan. The requirement for PMCF studies is found in Annex X, 1.1c of the Medical Device Directive (http://bit.ly/M5MDD).
Most orthopedics manufacturers attempt to provide a justification for not conducting PMCF studies, yet implant recalls and the prevalence of revision surgery have increased the scrutiny around these justifications. Hamish Forster (www.linkedin.com/pub/hamish-forster/19/643/494), a Notified Body auditor for BSI, wrote a white paper on “The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up.” You can find his paper on Orthoworld’s BoneZone website (http://bit.ly/BZPMCF).
If you are interested in reading more about the requirements for PMCF studies, you can also read the article that Dr. Dov Gal (http://bit.ly/DovGal) and I wrote for BoneZone (http://bit.ly/BZPMCFArticle) that was published on September 3, 2013.