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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Surgical indication determined by:

‣ Lower back pain and/or lower extremity pain for more than 3 months.

⁃ Pain refractory to conservative medical management (analgesics, physical therapy, epidural block).

⁃ Clinical criterion of neurogenic claudication defined as a score ≥11 on the N-CLASS scale.

⁃ Preoperative magnetic resonance imaging (MRI) showing lumbar canal stenosis.

• Patient consents to the proposed surgical intervention.

• Patient agrees to participate in the study by signing the informed consent form.

Locations
Other Locations
Spain
Hospital Clínico San Carlos
RECRUITING
Madrid
Contact Information
Primary
Juan P Castaño-Montoya, M.D., M.Sc.
juanpcas@ucm.es
+34669345474
Backup
Angela M Carrascosa-Granada, M.D., M.Sc.,Ph.D.
amaca3582@gmail.com
+34654849458
Time Frame
Start Date: 2025-04-21
Estimated Completion Date: 2026-10
Participants
Target number of participants: 24
Treatments
Experimental: Pressure-guided laminectomy (PGL)
Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.
Active_comparator: Non-pressure-guided laminectomy (NPGL)
Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.
Related Therapeutic Areas
Sponsors
Collaborators: FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS, Hospital San Carlos, Madrid
Leads: Universidad Complutense de Madrid

This content was sourced from clinicaltrials.gov