UnknownNot Applicable

Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression

20 participantsStarted 2022-06-01

Plain-language 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 treating lumbar disc herniation (LDH).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Change in Oswestry Disability Index (ODI)

Timeframe: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively

Change in Roland Morris Disability Questionnaire (RMDQ)

Timeframe: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively

Trial details

NCT IDNCT05270486

SponsorCentre Hospitalier Régional de la Citadelle

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Cervical Foraminal Stenosis trials