Radiographic and Patient-Reported Outcomes of Lordotic Versus Non-lordotic Static Interbody Devices in Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Longitudinal Comparative Cohort Study.

Introduction Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is increasingly used to treat lumbar degenerative pathology. Its effect on sagittal parameters remains controversial. Static and expandable lordotic interbody devices (cages) were developed to improve segmental and overall lumbar lordosis. This study aimed to compare the radiographic and patient-reported outcomes (PROs) between static lordotic and non-lordotic titanium cages in patients undergoing 1-2 level MI-TLIF for degenerative conditions.  Methods We reviewed consecutive eligible patients who underwent 1-2 level MI-TLIF (7/2017-11/2019) at a single institution by multiple surgeons. Standing X-rays and PROs were collected at preoperative, 1-month, and 6-month postoperative intervals. Using univariate analyses, we compared the two cohorts regarding confounders, radiographic parameters, and proportions of patients reaching minimal clinically important difference (MCID) for PROs. Results One-hundred-twenty-five patients were reviewed. Forty-seven had lordotic and seventy-eight non-lordotic cages. The lordotic cohort was significantly younger than the non-lordotic (55.9 years vs. 60.7 years, p= 0.042). The baseline radiographic parameters were not significantly different between cohorts. At the preoperative-6-month interval, the lordotic cohort had significant improvement in lumbar lordosis versus non-lordotic cohort (2.95° ± 7.2° vs. -0.3° ± 7.1°, p=0.024). Both cohorts showed improvement in segmental lordosis, anterior and posterior interspace height, and low subsidence grade with no significant difference between cohorts at all intervals. Overall, 69.1-83.8% of patients achieved MCID in all PROs with no significant difference between cohorts. Conclusions The use of a static lordotic titanium cage in 1-2 level MI-TLIF did not result in significantly different radiographic improvements or PROs compared with a non-lordotic cage.

The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol.

INTRODUCTION: Ketorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control. METHODS AND ANALYSIS: This is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay. ETHICS AND DISSEMINATION: Ethical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03278691.