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

NCT07026305 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Lumbar Canal Stenosis
  • Lumbar Spinal Stenosis
  • Lumbar Spinal Stenosis (LSS)

Interventions

PROCEDURE

Laminectomy without pressure guidance (LWPG)

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

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.

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

    collaborator OTHER

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Juan P Castaño-Montoya, M.D.,M.Sc. · Universidad Complutense de Madrid

  • Angela M Carrascosa-Granada, M.D.,M.Sc.,Ph.D. · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2026-06-30
Completion
2026-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026305 on ClinicalTrials.gov