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Upper Limb Disorders
Lumbar Disc
What does the FDA and NICE say?
Artificial disc use is currently in different phases of development and clinical trials in the United States under strict FDA (Food and Drug Administration) guidelines3,7,9,10, but has been used in a number of European countries for over 10 years4,8. There has been nearly 20 years experience in the use of the Charit� III (unconstrained) and ProDisc II (semi-constrained), both of which have completed their randomized enrolments, and are currently in Continued Access non-randomized modes. The Maverick (metal on metal articulation) and FlexiCore lumbar discs are actively enrolling patients with single-level disease.
There are a wide selection of new products, procedures and techniques currently in development to enhance spine surgery with artificial discs, and many spine surgeons believe that artificial disc technology holds real promise for significantly improving the standard of care for many patients. Provisional comparative data from the larger investigational study centres reveals improved visual pain analogue score (VPAS) and Oswestry low back functional scores in arthroplasty patients, and suggest earlier return to work with restoration of lumbar motion as compared to the control fusion group5,9,10.
Results of the FDA multi-centre randomised study on the Charit� III have been released showing significantly more patients improving following disc replacement than those who had a fusion1. Results of the Prodisc II study are also very encouraging and will be released in late 2005. Based on the Charit� III study, NICE have issued full guidance for lumbar disc replacement.
(Further information about the National Institute for Clinical Excellence (NICE) and the Interventional Procedures Programme can be found on the NICE website (
www.nice.org.uk). A copy of the full guidance on prosthetic intervertebral disc replacement is on the NICE website (
www.nice.org.uk/IPG100guidance), or you can order a copy from the website or by telephoning the NHS Response Line on 0870 1555 455 and quoting reference number N0749.)
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