Prospective assessment of the safety and early outcomes of sublaminar band placement for the prevention of proximal junctional kyphosis.

OBJECTIVE Proximal junctional kyphosis (PJK) can progress to proximal junctional failure (PJF), a widely recognized early and serious complication of multisegment spinal instrumentation for the treatment of adult spinal deformity (ASD). Sublaminar band placement has been suggested as a possible technique to prevent PJK and PJF but carries the theoretical possibility of a paradoxical increase in these complications as a result of the required muscle dissection and posterior ligamentous disruption. In this study, the authors prospectively assess the safety as well as the early clinical and radiological outcomes of sublaminar band insertion at the upper instrumented vertebra (UIV) plus 1 level (UIV+1). METHODS Between August 2015 and February 2017, 40 consecutive patients underwent either upper (T2-4) or lower (T8-10) thoracic sublaminar band placement at the UIV+1 during long-segment thoracolumbar arthrodesis surgery. Outcome measures were prospectively collected and uploaded to a web-based REDCap database specifically designed to include demographic, clinical, and radiological data. All patients underwent clinical assessment, as well as radiological assessment with anteroposterior and lateral 36-inch whole-spine standing radiographs both pre- and postoperatively. RESULTS Forty patients (24 women and 16 men) were included in this study. Median age at surgery was 64.0 years with an IQR of 57.7-70.0 years. Median follow-up was 12 months (IQR 6-15 months). Three procedure-related complications were noted, including 2 intraoperative cerebrospinal spinal fluid leaks and 1 transient neurological deficit. Median visual analog scale (VAS) scores for back pain significantly improved after surgery (preoperatively: 8.0, IQR 6.0-10.0; 1-year follow-up: 2.0, IQR 0.0-6.0; p = 0.001). Median Oswestry Disability Index (version 2.1a) scores also significantly improved after surgery (preoperatively: 56.0, IQR 45.0-64.0; 1-year follow-up: 46.0, IQR 22.2-54.0; p < 0.001). Sagittal vertical axis (preoperatively: 9.0 cm, IQR 5.3-11.6 cm; final follow-up: 4.7 cm, IQR 2.0-6.6 cm; p < 0.001), pelvic incidence-lumbar lordosis mismatch (24.7°, IQR 11.2°-31.2°; 7.7°, IQR -1.2° to 19.5°; p < 0.001), and pelvic tilt (28.7°, IQR 20.4°-32.6°; 17.1°, IQR 10.8°-25.2°; p < 0.001) were all improved at the final follow-up. While proximal junctional (PJ) Cobb angles increased overall at the final follow-up (preoperatively: 4.2°, IQR 1.9°-7.4°; final follow-up: 8.0°, IQR 5.8°-10.3°; p = 0.002), the significant increase was primarily noted starting at the immediate postoperative time point (7.2°, IQR 4.4°-11.8°; p = 0.001) and not beyond. Three patients (7.5%) developed radiological PJK (mean ΔPJ Cobb 15.5°), while there were no instances of PJF in this cohort. CONCLUSIONS Sublaminar band placement at the UIV+1 during long-segment thoracolumbar instrumented arthrodesis is relatively safe and is not associated with an increased rate of PJK. Moreover, no subjects developed PJF. Prospective large-scale and long-term analysis is needed to define the potential benefit of sublaminar bands in reducing the incidence of PJK and PJF following surgery for ASD. Clinical trial registration no.: NCT02411799 (clinicaltrials.gov).