Pressure-guided limited bone removal versus standard laminectomy for 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.
This test will see if using epidural pressure to guide a smaller bone removal works as well as standard open laminectomy for people with symptomatic lumbar spinal stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT07026305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic lumbar canal stenosis and neurogenic claudication lasting >3 months, refractory to conservative treatment, with MRI confirmation and who consent to surgery.
Not a fit: Patients with foraminal or lateral recess stenosis, symptomatic disc herniation at the treated level, spondylolisthesis > Grade I, radiological instability, severe scoliosis, compression fracture, or prior surgery at the level are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, patients might get comparable symptom relief with less bone removal, which could reduce tissue trauma and speed recovery.
How similar studies have performed: The pressure-guided decompression approach is relatively novel with limited prior clinical trial evidence, although physiological studies and small series have suggested a link between epidural pressure reduction and symptom improvement.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.