Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression
NCT ID: NCT05270486
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2022-06-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A
group A undergoing TELD (transforaminal endoscopic lumbar discectomy) with electromagnetic navigation system
Electromagnetic navigation system
The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH).
Group B
group B undergoing TELD with X-ray fluoroscopy (gold standard)
No interventions assigned to this group
Interventions
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Electromagnetic navigation system
The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH).
Eligibility Criteria
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Inclusion Criteria
2. typical clinical symptoms and consistent imaging evidence of mono-radiculopathy LDH; or single level LSS combined with disc herniation
3. 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
4. VAS pain ≥ 6/10
5. Absence of significant instability;
Exclusion Criteria
2. severe central stenosis, cauda equina syndrome, spinal instability, active infection, and serious calcified fragments
3. previous lumbar treatment with spinal surgery, ozone intervention, or radiofrequency ablation
4. unwilling or unable to participate in treatment and complete follow-up
5. Multi-level disc pathology
6. MRC paresis \<4/5
7. Pregnancy
8. participation in another clinical trial
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Régional de la Citadelle
OTHER
Responsible Party
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Remacle Thibault
Principal Investigator, MD, PhD, Neurosurgeon
Other Identifiers
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EM Assisted TELD
Identifier Type: -
Identifier Source: org_study_id
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