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

Phase 2

• Conditions: surgery; umbar spinal stenosis with unilateral radiculopathy; spinal stenosis; radiculopathy; outcome

• Registration Number: TCTR20240810003
• Lead Sponsor: Graduate Affairs, Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-10
• Last Update Posted: 19 August 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of pre-operative and post-operative pain 12 months Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Difference of pre-operative and post-operative pain 1 day, 3 weeks, 3 months, 6 months, 12 months Visual analogue scale,Difference of pre-operative and post-operative functional score 1 day, 3 weeks, 3 months, 6 months, 12 months Oswestry Disability Index (ODI),Overall success in terms of patient's satisfaction 12 months Modified MacNab criteria,Intra-operative blood loss during operation Operative note,Surgical time during operation Operative note,Complication such as dural tear, epidural hematoma, wound complication during operation and after discharge Operative note, IPD record, and OPD record if the wound complication occurs after discharge,Difference of pre-operative and post-operative Dural sac cross-sectional area 3 months MRI image using Synapse PACS application to measure the area ,Post-operative instability of the spine 12 months Plain film X-ray of flexion-extension LS spine,Recurrence of symptoms and revision surgery 12 months Patient reported-outcome using questionnaire interview