Prema Thavaneswaran1, Meegan Vandepeer. 1. Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S), Royal Australasian College of Surgeons, Adelaide, South Australia, Australia.
Abstract
BACKGROUND: Low back pain represents a significant disease burden in Australia. Lumbar artificial intervertebral disc replacement (AIDR) has emerged as an alternative surgical option to lumbar fusion for patients suffering from axial low back pain as a result of degenerative disc disease. OBJECTIVES: The aim of this review was to assess the safety and effectiveness of lumbar AIDR for patients suffering from significant axial back pain and/or radicular (nerve root) pain, secondary to disc degeneration or prolapse, who have failed non-operative treatment. METHODS: A systematic search of several electronic databases was conducted between January 2005 and April 2012 to identify relevant randomized controlled trials and non-randomized comparative studies. Inclusion of studies was established through the application of a predetermined protocol by two independent reviewers. RESULTS: Six randomized controlled trials (comprising nine studies) and one non-randomized comparative study comparing lumbar AIDR with lumbar fusion were included in this review. For the majority of adverse events reported, there were no obvious differences in incidence rates between the two treatment groups, and serious adverse events were rare in both groups. Following lumbar AIDR, effectiveness outcomes including Oswestry Disability Index scores, procedural success rates, pain scores, narcotic medication use and patient satisfaction were generally significantly better than, or equivalent to, outcomes achieved following lumbar fusion. CONCLUSIONS: In the short to medium term, the safety and effectiveness of lumbar AIDR appears to be comparable to that of lumbar fusion.
BACKGROUND:Low back pain represents a significant disease burden in Australia. Lumbar artificial intervertebral disc replacement (AIDR) has emerged as an alternative surgical option to lumbar fusion for patients suffering from axial low back pain as a result of degenerative disc disease. OBJECTIVES: The aim of this review was to assess the safety and effectiveness of lumbar AIDR for patients suffering from significant axial back pain and/or radicular (nerve root) pain, secondary to disc degeneration or prolapse, who have failed non-operative treatment. METHODS: A systematic search of several electronic databases was conducted between January 2005 and April 2012 to identify relevant randomized controlled trials and non-randomized comparative studies. Inclusion of studies was established through the application of a predetermined protocol by two independent reviewers. RESULTS: Six randomized controlled trials (comprising nine studies) and one non-randomized comparative study comparing lumbar AIDR with lumbar fusion were included in this review. For the majority of adverse events reported, there were no obvious differences in incidence rates between the two treatment groups, and serious adverse events were rare in both groups. Following lumbar AIDR, effectiveness outcomes including Oswestry Disability Index scores, procedural success rates, pain scores, narcotic medication use and patient satisfaction were generally significantly better than, or equivalent to, outcomes achieved following lumbar fusion. CONCLUSIONS: In the short to medium term, the safety and effectiveness of lumbar AIDR appears to be comparable to that of lumbar fusion.