Authors' objectives:

The primary objectives of this systematic review are to investigate the safety and effectiveness of intervertebral cervical disc implants, in particular, Bryan's disc, in treating degenerative disc disease (DDD) and to investigate its relative advantage compared to cervical fusion in treating DDD. The secondary objective of this review is to summarize available systematic reviews on artificial disc implantation in general.

Authors' recommendations: 1. The concept of establishing spinal pain as being caused by Degenerative Disc Disease is still problematic and unclear. 2. Artificial intervertebral disc has been in use for almost two decades in mainly European and some Asian countries 3. As of December 29, 2003, there are two artificial disc implants that have been licensed for use in Canada. These products include SB Charite III for lumbar disc and Bryan Cervical Disc Prosthesis. 4. Recently, SB Charite III has been approved by the US FDA for use in treating pain associated with lumbar spinal disc degeneration. The approval was given, based on the US FDA investigational device exemption multicenter randomized controlled trial study conducted by the manufacturer. It should be noted that our appraisal of this study suggests some areas of concern. 5. At present, Prosthetic Disc Nucleus is under investigation in Canada and the US. 6. Despite the claims that Bryan's cervical disc has been implanted in over 5000 patients worldwide, to date, there are only 9 published papers on the application of Bryan's cervical disc. These publications are all case series types (level 4-5 evidence). 7. The insertion of artificial cervical disc has many technical issues and is not without risk. Complications, including the need for re-surgery, device migration and physiological bodily response to the wear debris of the implant have been reported. 8. Due to the lack of direct comparison published data on cervical disc prosthesis against, for example, discectomy with or without fusion, as well as long term follow-up (> 10 years) safety and efficacy of artificial cervical disc still cannot be established. It is expected that, in the near future, short-term randomized controlled trial data will be available from the US FDA Device Exemption Study results. 9. As such, at present, artificial intervertebral disc, in particular artificial cervical discs, should be considered still at an experimental stage.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.worksafebc.com/health_care_providers/related_information/evid ence_based_medicine/default.asp

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: WorkSafeBC

Contact Address: 6591 Westminster Highway, Richmond, BC, V7C 1C6 Canada. Tel: 604-231-8417; Fax: 604-279-7698

Contact Name: ebpg@worksafebc.com

Contact Email: ebpg@worksafebc.com

Copyright: WorkSafe BC