Journal of neurosurgery. Spine
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Case Reports Randomized Controlled Trial Multicenter Study
A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation.
OBJECTIVE Chemonucleolysis with condoliase has the potential to be a new, less invasive therapeutic option for patients with lumbar disc herniation (LDH). The aim of the present study was to determine the most suitable therapeutic dose of condoliase. METHODS Patients between 20 and 70 years of age with unilateral leg pain, positive findings on the straight leg raise test, and LDH were recruited. ⋯ CONCLUSIONS Condoliase significantly improved clinical symptoms in patients with LDH and was well tolerated. While all 3 doses had similar efficacy, the incidence of adverse drug reactions and decrease in disc height were dose dependent, thereby suggesting that 1.25 U would be the recommended clinical dose of condoliase. Clinical trial registration no.: NCT00634946 (clinicaltrials.gov).
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Multicenter Study Clinical Trial
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). ⋯ 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).