Review of safety in endoscopic laser foraminoplasty for the management of back pain.

OBJECTIVE: The purpose of this study was to analyze the incidence and gravity of reported complications that arise in spinal surgery and assess the comparative safety, or otherwise, of endoscopic laser foraminoplasty (ELF).

BACKGROUND DATA: Chemonucleolysis, decompression, discectomy, and fusion have long been cited as treatments for chronic low back pain. Over recent years newer, less invasive surgical techniques have become available, one such being ELF. Although minimally invasive, the beneficial outcome must be interpreted in relation to concerns regarding the safety of the procedure and its risks relative to those of other forms of spinal surgery. The Spinal Foundation, Rochdale has performed 958 ELFs and has collated a comprehensive database of the results of all these operations. These prospective records provided the basis for a comparison of the safety of ELF to that reported with other spinal surgical techniques.

METHODS: A total of 958 procedures have been performed on 716 patients. Complications that arose during the operation and the postoperative phase of 6 weeks following the procedure were elicited from patient records. These data were correlated and compared to a meta-analysis of randomized controlled clinical trial data of complications arising during and after conventional spinal surgery. The SPSS (statistical package for social sciences) and CIA (confidence interval analysis) statistical packages were used to draw conclusions regarding the safety of ELF.

RESULTS: The cohort integrity of operation and outpatient review records at 6 weeks after surgery was 100%. In 958 ELFs performed, 24 complications occurred in 23 patients. There were 9 cases of discitis (1 infective, 8 aseptic) (0.9%), 1 dural tear (0.1%), 1 deep wound infection (0.1%), 2 patients suffered a foot drop (1 transient) (0.2%), 1 myocardial infarction (0.1%), 1 erectile dysfunction (0.1%), and 1 patient who developed panic attacks post-operatively (0.1%). This amounts to an overall surgical complication rate of 1.6%. Magnetic resonance imaging (MRI) follow up of clinically symptomatic patients highlighted 8 residual disc herniations (0.8%). Meta-analysis of randomized controlled trials of conventional spinal surgery for adult onset degenerative disc disease and/or sciatic pain reported overall complication rates for fusion (11.8%), decompression (7.6%), discectomy (6.0%), and chemonucleolysis (9.6%).

CONCLUSIONS: The complication rate of ELF is shown to be significantly lower than that reported following conventional spinal surgery (p < 0.01). From these results, we conclude that ELF as a treatment for chronic low back pain and sciatica presents less risk to a patient than conventional methods of spinal surgery.