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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240810003
Enrollment
52
Registered
2024-08-10
Start date
2024-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar spinal stenosis with unilateral radiculopathy spinal stenosis radiculopathy surgery outcome

Interventions

Using fluoroscopy to guide the incision, aiming at lower lamina dissecting mid-disc space of the Index level. The incision is 1 cm deep to fascia. Apply Trocar deep to lower lamina followed by blunt d
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Interlaminar endoscopic lateral recess decompression(IE-LRD),Lumbar endoscopic unilateral laminotomy and bilateral decompression(LE-ULBD)

Sponsors

Graduate Affairs, Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Difference of pre-operative and post-operative pain 12 months Visual analogue scale

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactParinya Phitchayanon

Faculty of Medicine, Chulalongkorn University

parinya.phi@outlook.com026494000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026