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


Spine. 2020;45(21):E1441-E1448. 

In This Article

Study Summary

The study population consisted of a total of 230 patients who were enrolled from seven sites throughout Germany during a 6-year period (March 2008 to July 2014). Relevant inclusion criteria included age > 40 years, VAS scores for back pain ≥ 50 mm, and radiographic findings of at least moderate stenosis at one or two adjacent levels from L3 to L5 with up to Grade 1 spondylolisthesis, and corresponding clinical symptoms necessitating surgical intervention. Subjects were randomized in a 1:1 fashion to undergo open microsurgical decompression alone (DA) or in conjunction with interlaminar stabilization using the Coflex device (D+ILS). In addition to recording ach patient was assessed for a previously validated binary Composite Clinical Success (CCS) measure which was defined by a decrease in ODI scores > 15, no additional operations or injections, stable or improved neurologic function, and no device- or procedure-related severe adverse events. In addition to recording narcotic usage, the authors also administered other secondary clinical outcome instruments such as the VAS, Zurich Claudication Questionnaire, and walking distance test; an independent core radiographic laboratory also measured any changes in foraminal and posterior disc height relative to baseline values.

The demographic characteristics of both groups were equivalent and the overall follow-up rate was 91% at the completion of the study. Although there were no significant differences between the patient-reported outcomes of the two cohorts at 2 years, the CCS was superior for the D+ILS subjects (P = 0.017). Patients in the DA group were also more likely to undergo secondary surgical intervention at the index level as well as injections (P = 0.055 and P = 0.0065, respectively). The D+ILS cohort was associated with reduced narcotic utilization and greater improvements in the Walking Distance Test than the DA controls. Foraminal and disc heights were largely maintained over time in the D+ILS group, whereas subjects undergoing decompression without stabilization were found to have less preservation of these dimensions at 2 years. According to the authors, these collective results serve to support the efficacy and durability of interlaminar stabilization as an adjunct to decompression for the surgical management of moderate to severe lumbar stenosis.