Compressible non-articulating disc prostheses a review of clinical and cost-effectiveness, safety and guidelines

Efforts have been underway to develop a new generation of devices, such as the M6-L (Spinal Kinetics, Sunnyvale, CA), which would more effectively mimic the shock absorption and flexural stiffness of a native disc. TDR is an insured service in some Canadian jurisdictions. Although the M6-L is not ye...

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Bibliographic Details
Corporate Author: Canadian Agency for Drugs and Technologies in Health
Format: eBook
Language:English
Published: Ottawa (ON) Canadian Agency for Drugs and Technologies in Health 2014, 20 March 2014
Series:Rapid response report
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Description
Summary:Efforts have been underway to develop a new generation of devices, such as the M6-L (Spinal Kinetics, Sunnyvale, CA), which would more effectively mimic the shock absorption and flexural stiffness of a native disc. TDR is an insured service in some Canadian jurisdictions. Although the M6-L is not yet licensed in Canada, surgeons are interested in its potential as an alternative to the ProDisc-L (Synthes Canada, Mississauga, ON) and A-MAV (Medtronic Sofamor Danek, Memphis, TN) prostheses, both of which are articulating discs. Given the challenging history of lumbar surgery and the variation in kinematic and biomechanical properties across device designs, choice of an artificial disc represents a major clinical practice issue
Research and development activity appears to be intense as, in recent years, at least 20 lumbar prostheses were under development or in clinical trials. Although all artificial discs are intended to achieve the same ends, there is considerable heterogeneity in design. TDR prostheses can be classified by mode of anchorage, surface and friction couple design, constrained or unconstrained motion, location of the centre of movement and compatibility with magnetic resonance imaging (MRI). Some sources further classify disc prostheses as uni-articulating, bi-articulating, or non-articulating based on the friction couple design but the distinction is uncommon and/or inconsistent in the literature. Uni- and bi-articulating designs rely on a mechanical interface (e.g., ball and socket or a variant thereof) whereas non-articulating designs do not (e.g., elastomeric, deformable core). Most existing discs, particularly articulating discs, do not replicate the elasticity of the native disc.
Treatment options for discogenic low back pain include both non-surgical and surgical options. Amongst the surgical options, spinal segment fusion has a long history and is often characterized as the surgical standard of care. Fusion aims to reduce pain by eliminating motion at the level of the diseased disc or discs but long term outcomes are poor and complications are common. Total disc replacement (TDR), which involves replacing a diseased disc with an artificial disc, is an increasingly popular surgical alternative. TDR is intended to restore normal spinal movement while also preventing adjacent level disc degeneration which may be associated with the kinematic and biomechanical changes produced by fusion. Studies suggest TDR is non-inferior to fusion, at least in the short term. Artificial discs have been under development and/or in use for more than 25 years.
Item Description:Title from PDF caption. - "CADTH rapid response service."
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