Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Spain / NCT07026305
Recruiting Not applicable

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

NCT07026305 · tracked via the Priya Life Science Spain tracker
Sponsor
Universidad Complutense de Madrid
Phase
Not applicable
Started
2025-04-21
Last updated
2025-06-24

Condition(s) studied

Lumbar Canal StenosisLumbar Spinal StenosisLumbar Spinal Stenosis (LSS)

Investigational drug(s) / intervention(s)

Pressure-guided laminectomy (PGL)Laminectomy without pressure guidance (LWPG)

Pressure-guided laminectomy (PGL): Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.

Laminectomy without pressure guidance (LWPG): Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.

Study 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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Zurich Claudication Questionnaire (ZCQ) - Symptom Severity subcategory. — At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.
    This scale consists of 7 items that evaluate the severity of symptoms over the last month on a numeric scale from 1 to 5, where 5 represents greater severity. A mean score of the items is calculated.

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico San Carlos Madrid Spain Recruiting

More Universidad Complutense de Madrid trials in Spain

Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns Recruiting
Dry Needling or Percutaneous Electrolysis for Managing Myofascial Trigger Points? Starting soon
Acute Effects of Active Breaks and Physically Active Learning in University Students Starting soon
Optimization of Surgical Hand Preparation Using Sorbectol Recruiting
Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07026305 on ClinicalTrials.gov ↗ ← All trials in Spain