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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversidad Complutense de Madrid

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

24 Participants
are divided into 2 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