Evidence-Based Recommendations for Spine Surgery

Alexander R. Vaccaro, MD, PhD, MBA; Charles G. Fisher, MD; Srinivas K. Prasad, MD; Alpesh A. Patel, MD, FACS; John Chi, MD, MPH; Kishore Mulpuri, MBBS, MHSc; Kenneth C. Thomas, MD, MHSc; Peter G. Whang, MD, FACS

Disclosures

Spine. 2020;45(21):E1441-E1448. 

In This Article

Study Summary

This study was designed as a multicenter, double-blind, randomized clinical trial which included patients between the age of 18 and 72 years who had experienced symptoms of lower extremity sciatica secondary to a lumbar disc herniation at a single level who had failed to respond to conservative therapies. Eligible subjects who were enrolled into the clinical trial were randomized to either open microdiscectomy which involved the detachment of the paraspinal musculature from the posterior elements or tubular discectomy through a muscle-splitting approach. The primary outcome was functional disability which was quantified using the modified Roland-Morris Disability Questionnaire for Sciatica; various secondary outcomes were also recorded including Visual Analogue Scale (VAS) scores for leg pain and low back pain, patient self-perceived recovery, complication, and incidence of reoperation. These individuals were evaluated at regular follow-up intervals up to 260 weeks after surgery, both in person as well as by written correspondence.

Of the 325 patients randomly assigned to undergo tubular (n = 166) or open microdiscectomy (n = 159), 5-year data was available for 63% of the study population and 73% had completed the 4- or 5-year clinical evaluation. There were no statistically significant differences between any of the primary or secondary outcome measures observed for the minimally invasive and open surgical cohorts at any time point during the entire follow-up period (mean Roland-Morris Disability Questionnaire scores and differences in VAS leg/back scores at 5 years and during the entire follow-up period; percentages of subjects reporting resolution of symptoms; and reoperation rates). Given that the long-term findings of the two treatment groups were essentially equivalent, the investigators concluded that the purported benefits of tubular discectomy were not borne out at 5 years.

processing....