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Clinical Trials/TCTR20240810003
TCTR20240810003
Not yet recruiting
Phase 2

Clinical outcome of lumbar spinal stenosis with unilateral symptoms undergoing full-endoscopic unilateral decompression compared to bilateral over-the-top decompression, Randomized controlled trial

Graduate Affairs, Faculty of Medicine, Chulalongkorn University0 sites52 target enrollmentAugust 10, 2024

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Graduate Affairs, Faculty of Medicine, Chulalongkorn University
Enrollment
52
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 10, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Graduate Affairs, Faculty of Medicine, Chulalongkorn University

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients have unilateral lumbar radiculopathy symptom
  • 2\. Patients have severe spinal stenosis, defined by Dural cross\-sectional area(DCSA) \< 75 mm2, and the pathology from MRI correlates with the symptom.
  • If patient has single level of radicular symptom but has multiple sites of stenosis, the patient will be included and the intervention will target the level that correlates with the symptom.
  • If patient has multiple sites of stenosis and multiple level of symptoms or unidentified as single level, the patient will not be included in the study.

Exclusion Criteria

  • 1\. Patient also has Neurologic claudication symptom
  • 2\. Patient has Cauda equina syndrome
  • 3\. Instability of the spine , defined as the X\-ray shows Spondylolisthesis more than grade 1 or Dynamic Lumbar X\-ray shows Translation \>4 mm, angulation change \>10 degree on flexion\-extension radiograph.
  • 4\. Patient has history of spinal infection
  • 5\. Patient has prior surgery of the Lumbar spine
  • 6\. Patient has prior spinal trauma less than 6 month
  • 7\. Patient cannot communicate

Outcomes

Primary Outcomes

Not specified

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