Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
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.
Universidad Complutense de Madrid
24 participants
Apr 21, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria10
- Foraminal or lateral recess stenosis.
- Symptomatic disc herniation at the segment to be treated.
- Spondylolisthesis > Grade I (Meyerding) (translation >25% of the vertebra) or spondylolysis.
- Radiological instability defined as >5 mm of anteroposterior translation on dynamic flexion-extension spine X-rays.
- Scoliosis with Cobb angle >30°.
- Compression fracture at the level to be treated.
- Prior surgery at the same segment to be treated.
- Prior infection at the segment to be treated.
- Contraindication for MRI.
- Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.
Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07026305