Authors' objectives:

This review aims to answer the following questions:

- What is the effectiveness of artificial disc replacements in people with degenerative disc disease (DDD) of the lumbar or cervical regions of the spine compared with spinal fusion surgery?

- Does an artificial disc reduce the incidence of adjacent segment degeneration (ASD) compared with spinal fusion?

- What is the major complications rate (device failure, reoperation) with artificial discs compared to surgical spinal fusion?

Authors' recommendations: Lumbar Artificial Disc Replacement Since the 2004 MAS HTPA, data from 2 RCTs and 6 case series studies have become available assessing the effectiveness and adverse events profile of lumbar artificial disc replacement (ADR) to treat DDD. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) quality of this evidence is moderate for effectiveness and for short-term (2 years follow up) complications but very low for adjacent segment degeneration. The effectiveness of lumbar ADR is no worse that spinal fusion for the treatment of lumbar DDD. The rates for device failure and neurological complications 2 years after surgery did not differ between ADR and fusion patients. Based on a Bayesian meta-analysis lumbar ADR is 79% superior to lumbar spinal fusion. The rate of major complications after lumbar ADR is estimated to range between 0%-13% per device implanted. The rate of ASD estimated in 1 case series report is 2% over an 11-year follow up period. Outcome data for lumbar artificial disc replacement beyond a 2-year follow up is not yet available. Cervical Artificial Disc Replacement Since the 2004 MAS HTPA, 4 case series studies have been added to the body of evidence assessing the effectiveness and adverse events profile of cervical ADR to treat DDD. The GRADE quality of this evidence is very low for effectiveness as well as for the adverse events profile. Sparse outcome data is available. Because data is sparse, the effectiveness of cervical ADR compared to spinal fusion cannot be determined at this time. The rate of major complications was assessed up to 2 years after surgery and estimated to range between 0-8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.

Authors' methods: Systematic review

Project Status: Completed

Year Published: 2006

URL for published report: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_adr_040106.pdf

URL for additional information: http://www.hqontario.ca/en/mas/mas_ohtas_tech_adr_040106.html

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Medical Advisory Secretariat

Contact Address: Medical Advisory Secretariat, 20 Dundas Street West, 10th Floor, Toronto, ON M5G 2N6 CANADA. Tel: 416-314-1092l; Fax: 416-325-2364;

Contact Name: MASinfo.moh@ontario.ca

Contact Email: MASinfo.moh@ontario.ca

Copyright: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care