A Comparative Analysis of Ultrasound versus Fluoroscopy-Guided Transforaminal Endoscopic Lumbar Discectomy: Protocol for a Randomized Clinical Trial Targeting Lumbar Disc Herniation.

Lumbar disc herniation (LDH) is a prevalent cause of chronic disability that often necessitates surgical intervention when conservative treatments fail. This study aims to compare the clinical efficacy and safety of ultrasound-guided transforaminal endoscopic lumbar discectomy (UG-TELD) against fluoroscopy-guided transforaminal endoscopic lumbar discectomy (FG-TELD) in a single-center, parallel, block-randomized trial involving 80 adult patients aged 18 to 75 years with MRI-confirmed radiculopathy unresponsive to at least six weeks of conservative management. Participants will be randomly assigned to receive either UG-TELD or FG-TELD, adhering to strict exclusion criteria such as prior spinal surgeries or significant neurological deficits. Primary efficacy endpoints include a 50% reduction in leg pain measured by the Visual Analog Scale (VAS) at three months, alongside a 40% improvement in the Oswestry Disability Index (ODI) or a score below 20% at six months. Safety will be evaluated through the incidence of major complications (Clavien-Dindo grade III or higher) within 90 days postoperatively and the reoperation rate after one year. Operational metrics like puncture time, fluoroscopy exposure, and assessments of healthcare provider well-being through burnout evaluations and procedural satisfaction surveys will also be analyzed. This pioneering randomized controlled trial seeks to establish UG-TELD as a viable, radiation-free alternative for LDH treatment, highlighting the need for advancements in surgical techniques to enhance safety and efficacy. Future multicenter studies are warranted to further validate these findings and optimize surgical protocols in spinal surgery.