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Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 24, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study title revisedv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate the theory of epidural pressure by comparing a surgical procedure that aims to perform less bone resection compared to conventional surgery in patients with lumbar spinal stenosis. The main questions it aims to answer is: Is bony decompression of the lumbar canal performed until normalization of epidural pressure not inferior to conventional surgery in achieving clinical improvement in patients with symptomatic lumbar canal stenosis? Researchers will: Compare conventional open laminectomy to bony decompression of the lumbar canal until normalization of epidural pressure is achieved. Participants will: * Be randomized to one of the two surgical interventions: laminectomy guided by epidural pressure measure or conventional laminectomy. * Visit the clinic for checkups and tests until 1 year of follow-up.
Trial Details
NCT Number NCT07026305
Lead Sponsor Universidad Complutense de Madrid
Collaborators: Hospital San Carlos, Madrid, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Conditions
(from sponsor)		 Lumbar Canal Stenosis, Lumbar Spinal Stenosis, Lumbar Spinal Stenosis (LSS)
Related terms Spinal Stenosis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov