SPINE-RISK VE is a prospective multicenter cohort study designed to develop and internally validate a multimodal preoperative predictive model for Failed Back Surgery Syndrome (FBSS), now classified as Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) per ICD-11 (code MG30.51), in Venezuelan adults patients undergoing elective lumbar spine surgery.
The model integrates three variable domains obtainable from routine preoperative evaluation at zero additional cost to the patient: (1) inflammatory laboratory biomarkers (C-reactive protein \[CRP\], neutrophil-to-lymphocyte ratio \[NLR\], albumin, glycated hemoglobin \[HbA1c\], erythrocyte sedimentation rate \[ESR\]); (2) preoperative lumbar magnetic resonance imaging (MRI) findings (Modic changes, Pfirrmann disc degeneration grade, foraminal stenosis, number of surgical levels, spondylolisthesis); and (3) validated psychosocial instruments (Patient Health Questionnaire-9 \[PHQ-9\], Pain Catastrophizing Scale \[PCS\], smoking status, benzodiazepine use, prior lumbar surgery).
Analysis proceeds in two phases: Phase 1 applies multivariable logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) variable selection to generate a printable clinical nomogram; Phase 2 applies a random forest machine learning algorithm with 10-fold cross-validation. Model reporting follows Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis plus Artificial Intelligence (TRIPOD+AI) guidelines.
SPINE-RISK VE aims to produce the first validated multimodal predictive model for PSPS-T2/FBSS was developed in a Latin American surgical cohort, providing neurosurgeons with an evidence-based preoperative risk stratification tool applicable without Additional technological infrastructure.
Age 18 years or older
Confirmed indication for elective lumbar spine surgery (discectomy, spinal fusion, or decompression) for degenerative lumbar disease
Availability of preoperative lumbar MRI (with and without gadolinium contrast) within 6 months before surgery
Availability of standard preoperative laboratory panel (CRP, CBC with differential, albumin, HbA1c, ESR) within 30 days before surgery
Emergency lumbar spine surgery
Active spinal infection or spinal tumor requiring oncological surgery
Traumatic spinal fracture as primary indication
Cognitive impairment preventing completion of self-report psychosocial instruments
Adult patients with degenerative lumbar spine disease undergoing elective lumbar surgery (discectomy, spinal fusion, or decompression) at three Venezuelan referral centers: Hospital Universitario de Caracas and two regional Neurosurgical referral centers in Venezuela. Consecutive recruitment during the study period. This population represents a low-middle income country (LMIC) Latin American surgical cohort not previously represented in published predictive models for PSPS-T2/FBSS
Cohort
Prospective
SPINE-RISK VE multimodal preoperative assessment
Other interventionAdult patients (18 years or older) with an indication for elective lumbar spine surgery (discectomy, spinal fusion, or decompression) for degenerative lumbar disease at three Venezuelan referral centers. All participants undergo standardized preoperative assessment, including inflammatory laboratory biomarkers, lumbar MRI morphological evaluation, and validated psychosocial instruments (PHQ-9, PCS). Primary outcome assessed at 12-month postoperative follow-up
Predictive accuracy of SPINE-RISK VE model for PSPS-T2/FBSS at 12 months
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the multimodal predictive model (Phase 1: LASSO logistic regression nomogram; Phase 2: random forest algorithm) for identifying patients who develop Persistent Spinal Pain Syndrome Type 2 (PSPS-T2/FBSS) at 12 months post-lumbar surgery, defined as NRS \>=4 AND ODI \>=40% at postoperative follow-up assessment. Target AUC \>=0.80 per Riley et al. (Stat Med 2020) Minimum criteria for clinical prediction models.
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juan jose valero quintero,MD
Lead sponsor
Universidad Central de Venezuela
Sponsor institution
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