Status:
UNKNOWN
Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression
Lead Sponsor:
Centre Hospitalier Régional de la Citadelle
Conditions:
Cervical Foraminal Stenosis
Cervical Disc Herniation
Eligibility:
All Genders
18-80 years
Brief Summary
There is a shallow learning curve with TELD (transforaminal endoscopic lumbar discectomy). The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for...
Eligibility Criteria
Inclusion
- age≥18 and ≤80 years;
- typical clinical symptoms and consistent imaging evidence of mono-radiculopathy LDH; or single level LSS combined with disc herniation
- recalcitrant pain despite proper conservative therapy (including analgesics, NSAIDs, corticoids infusion under CT guidance and physical therapy) for at least 3 months before surgery and/or neurological deficit in the territory of the irritated nerve root
- VAS pain ≥ 6/10
- Absence of significant instability;
Exclusion
- serious underlying disease or mental illnesses
- severe central stenosis, cauda equina syndrome, spinal instability, active infection, and serious calcified fragments
- previous lumbar treatment with spinal surgery, ozone intervention, or radiofrequency ablation
- unwilling or unable to participate in treatment and complete follow-up
- Multi-level disc pathology
- MRC paresis \<4/5
- Pregnancy
- participation in another clinical trial
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05270486
Start Date
June 1 2022
End Date
December 31 2023
Last Update
March 8 2022
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