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RECRUITING
NCT07026305
NA

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

Sponsor: Universidad Complutense de Madrid

View on ClinicalTrials.gov

Summary

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.

Official title: Non-inferiority of Osseous Decompression of the Lumbar Canal Until Normalization of Epidural Pressure Compared to Conventional Open Laminectomy in Patients With Symptomatic Lumbar Spinal Stenosis.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-04-21

Completion Date

2026-10

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

PROCEDURE

Pressure-guided laminectomy (PGL)

Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.

PROCEDURE

Laminectomy without pressure guidance (LWPG)

Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.

Locations (1)

Hospital Clínico San Carlos

Madrid, Spain