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IntroductionSacroiliac joint (SIJ) dysfunction has been shown to cause significant morbidity. Current treatment includes conservative management and surgical intervention. Previously published data reporting clinical and surgical outcomes reached conflicting conclusions. This protocol aims to conduct a meta-analysis to determine fusion rates and patient-reported outcomes of minimally invasive (MIS) SIJ fusions compared with conservative treatment.Methods and analysisWe drafted our protocol according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will search PubMed, Embase and the Cochrane Library, supplemented by manual search when necessary. Two independent reviewers will screen for eligibility by title/abstract, then full text, arbitrated by a third reviewer if necessary. The two reviewers will carry out a risk of bias assessment using the Cochrane Collaboration Risk of Bias tool for randomised controlled trial and the Methodological Index for Non-Randomised Studies tool for observational cohort studies. A third reviewer will arbitrate any disagreement. We will perform data synthesis using Review Manager (RevMan for Windows, V.5.4.1, The Cochrane Collaboration, 2020) and Comprehensive Meta-Analysis (V.3.3.070). Meta-bias will be evaluated and confidence determined using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.Ethics and disseminationEthical approval for this review will not be required as no patient data is being collected. The results of this study will be submitted for publication in peer-reviewed journals.PROSPERO registration numberCRD42021273481.

Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses.We sought to demonstrate noninferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar interbody fusion. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period.This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis.Adults with degenerative spinal conditions eligible to undergo a one to three-level MIS transforaminal lumbar interbody fusion (TLIF).Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent, length of stay, and drug-related complications. Self-reported and functional measures include validated visual analog scale, short-form 12, and Oswestry Disability Index.A double-blinded, randomized placebo-controlled, noninferiority trial of patients undergoing 1- to 3-level MIS TLIF was performed with bone morphogenetic protein (BMP). Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15 mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as milligram morphine equivalence, pain scores, length of stay (LOS), and quality-of-life outcomes. Univariate analyses were performed. The present study provides results from a planned interim analysis.Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion of solid fusion between the ketorolac and placebo groups did not reach inferiority (p=.072, 95% confidence interval, -.07 to .21). There was a significant reduction in total/48-hour mean opioid consumption (p.001) and LOS (p=.001) for the ketorolac group while demonstrating equivalent mean pain scores in 48 hours postoperative (p=.20). There was no significant difference in rates of perioperative complications.Short-term use of low-dose ketorolac in patients who have undergone MIS TLIF with BMP demonstrated noninferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control.

BACKGROUND CONTEXT Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses. PURPOSE We sought to demonstrate non-inferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar fusions. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period. STUDY DESIGN/SETTING This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis. PATIENT SAMPLE Adults with degenerative spinal conditions eligible to undergo a 1- to 3-level minimally invasive lumbar spinal fusion. OUTCOME MEASURES Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent (MME), length of stay (LOS), and drug-related complications. Self-reported and functional measures include validated visual analog scale (VAS), short-form 12 (SF-12), and Oswestry Disability Index (ODI). METHODS A double-blinded, randomized placebo-controlled, non-inferiority trial of patients undergoing 1- to 3-level minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) was performed. Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as MME, pain scores, LOS, and quality-of-life (QoL) outcomes. Univariate and multivariate analyses were performed. The present study provides results from a planned interim analysis. RESULTS Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion for solid fusion between the ketorolac and placebo groups did not reach inferiority (.072, 95% CI, -.07-.21). There was a significant reduction in total/48-hour mean opioid consumption (p CONCLUSION Short-term use of low-dose ketorolac in patients who have undergone MIS lumbar fusion demonstrated favorable results suggesting non-inferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control. FDA DEVICE/DRUG STATUS Not applicable.