RESUMEN
Background: The effectiveness of transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar interbody fusion (PLIF) in patients with single-level spondylolisthesis has not been substantiated. To address the evidence gap, a well-powered randomized controlled non-inferiority trial comparing the effectiveness of TLIF with PLIF, entitled the Lumbar Interbody Fusion Trial (LIFT), was conducted. Methods: In a multicenter randomized controlled non-inferiority trial among five Dutch hospitals, 161 patients were randomly allocated to either TLIF or PLIF (1:1), stratified according to study site. Patients and statisticians were blinded for group assignment. All patients were over 18 years old with symptomatic single-level degenerative, isthmic or iatrogenic lumbar spondylolisthesis, and eligible for lumbar interbody fusion surgery through a posterior approach. The primary outcome was change in disability measured with the Oswestry Disability Index (ODI) from preoperative to one year postoperative. The non-inferiority limit was set to 7.0 points based on the MCID of ODI. Secondary outcomes were change in quality-adjusted life years (QALY) assessed with EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) and Short Form Health Survey (SF-36), as well as back and leg pain (Numerical rating scale, NRS), anxiety and depression (Hospital Anxiety Depression Scale; HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and complications. Trial registration: Netherlands Trial Registry, number 5722 (registration date March 30, 2016), Lumbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis. Findings: Patients were included between August 2017 and November 2020. The total study population was 161 patients. Total loss-to-follow-up after one year was 16 patients. Per-protocol analysis included 66 patients in each group. In the TLIF group (mean age 61.6, 36 females), ODI improved from 46.7 to 20.7, whereas in the PLIF group (mean age 61.9, 41 females), it improved from 46.0 to 24.9. This difference (-4.9, 90% CI -12.2 to +2.4) did not reach the non-inferiority limit of 7.0 points in ODI. A significant difference in the secondary outcome measurement, QALY (SF-36), was observed in favor of TLIF (P < 0.05). However, this was not clinically relevant. No difference was found for all other secondary outcome measurements; PROMs (EQ-5D, NRS leg/back, HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and perioperative and postoperative complications. Interpretation: For patients with single-level spondylolisthesis, TLIF is non-inferior to PLIF in terms of clinical effectiveness. Disability (measured with ODI) did not differ over time between groups. Funding: No funding was received for this trial.
RESUMEN
RATIONALE, AIMS AND OBJECTIVES: Low-urgent Emergency Department (ED) attendances are a known contributing factor to ED crowding. In the Netherlands, general practitioners (GPs) have direct access to radiology facilities during office hours. Patients with radiographically confirmed traumatic injuries are subsequently referred to the ED. We analysed these ED trauma patients' characteristics, provided treatments and ED discharge diagnoses to identify the possibility of alternative care pathways. METHODS: Single-centre retrospective observational study of trauma patients referred to the ED by the radiology department during office hours (January 2017-December 2017). Data were obtained from patient records. Descriptive statistics were used to analyse the extracted data. RESULTS: A total of 662 patients were included. The median age was 42 years (range: 1-100, interquartile range (IQR): 15-63) and patients presented to the ED with a median delay of 1 day (range: 0-112 days, IQR: 0-5). Most patients were referred for injuries involving the upper extremities (61.5%) and lower extremities (30%). A total of 48 additional diagnoses were made in the ED. The majority of injuries was classified as 'minor' (29.5%) or 'moderate' (68.3%) on the Abbreviated Injury Scale (AIS). The median length of stay in the ED was 65 min (range: 7-297 min, IQR: 43-102). CONCLUSION: Most patients presented with low acuity injuries and often with a notable delay to the ED. This suggests that the majority of these patients do not necessarily need ED treatment, which may provide an opportunity to counter ED crowding.