About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pressure-guided laminectomy (PGL)
- Laminectomy without pressure guidance (LWPG)
Treatment groups
Sponsors and collaborators
Universidad Complutense de Madrid
Lead sponsor
Hospital San Carlos, Madrid
Collaborator
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Collaborator