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

As part of this randomized controlled trial, 152 patients with fractures localizing to the thoracolumbar junction (T11-L2) were screened for enrollment and 68 were excluded due to various well-documented criteria. The remaining 84 subjects were randomly assigned to the two treatment groups of which 10 were subsequently withdrawn from the investigation due to reoperation or inadequate follow-up. All patients underwent an instrumented posterolateral fusion with the use of autologous bone harvested from the iliac crest. In the SSIFL cohort, pedicle screws were inserted within the fractured vertebral body as well as one level above and below, whereas for the LS group the segmental fixation was placed two levels above and below but not in the fracture itself.

Patient demographics (including smoking status) and radiographic parameters were recorded at baseline. The trial design included scheduled evaluations at 3 month intervals up to 24 months. At the 6, 12, and 24 month visits, subjects were assessed using a number of clinical outcomes instruments (ODI, VAS) and radiographic parameters (kyphosis angle, sagittal index, anterior vertebral body height loss). Any surgery-associated complications were documented at the end of the follow-up period.

The primary comparison of interest was the fusion rates of the two groups. Fusion status was defined according to the degree of bone activity at the fractured level compared with nonfractured levels on technetium 99-methylendiphosphonate (Tc-99m) bone scintography and single photo emission computed tomography studies, with high uptake indicating that a successful arthrodesis had not occurred. Other secondary outcomes that were assessed were the within-group changes in the clinical scores (from 6 mo to 12 and 24 mo) and radiological measures (from baseline to 6, 12, and 24 mo), as well as the between-group comparisons of these various scores/measures at each time point. The authors also analyzed the relationship between smoking and fusion rates in this patient population.

In this study, the fusion rate observed for the SSIFL group was significantly greater than that of the LS cohort (61.5% vs. 37.1%, P = 0.036). Not surprisingly, the fusion rate was higher for nonsmokers than smokers; patient with healed fractures reported improved clinical improvements but the radiographic outcomes of these populations were equivalent. However, there were no significant differences between the corresponding clinical scores and radiological measures of the SSIFL and LS groups at 2 years. Thus, the authors conclude that short-segment fixation with screws placed within the fractured vertebral body is a safe and effective technique for stabilizing unstable injuries of the thoracolumbar junction which may result in shorter recovery times than the use of longer constructs.

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