Pressure-guided limited bone removal versus standard laminectomy for symptomatic lumbar spinal stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-blind, randomized, non-inferiority trial that compares conventional open laminectomy to a pressure-guided laminectomy in which bone is removed until epidural pressure normalizes. Adults with symptomatic lumbar canal stenosis and neurogenic claudication who have failed conservative care and have confirmatory MRI are randomized 1:1 and remain blinded to group assignment. Baseline and follow-up clinical scales (ZCQ, NPRS, ODI, JOABPEQ) are collected and patients are followed for one year after surgery. A single neurosurgeon at Hospital Clínico San Carlos performs the procedures using an intraoperative Codman microsensor for epidural pressure guidance and the study has no industry sponsorship.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Hospital Clínico San Carlos
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Juan P Castaño-Montoya, M.D.,M.Sc. — Universidad Complutense de Madrid
• Study coordinator: Juan P Castaño-Montoya, M.D., M.Sc.
• Email: juanpcas@ucm.es
• Phone: +34669345474

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.