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

Centre Hospitalier Régional de la Citadelle20 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Foraminal Stenosis Cervical Disc Herniation

Interventions

Electromagnetic navigation systemPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age≥18 and ≤80 years; 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: 1. serious underlying disease or mental illnesses 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

Outcomes

Primary Outcomes

Change in Oswestry Disability Index (ODI)

0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.

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

Change in Roland Morris Disability Questionnaire (RMDQ)

This is a 24 item questionnaire. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability)

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

Secondary Outcomes

Back Pain Numerical Rating Score (BPNRS)

Patient is asked to rate his pain between 11 points (0-11; 0=no pain and 10=worst pain imaginable)

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

Leg Pain Numerical Rating Score (LPNRS)

Patient is asked to rate his pain between 11 points (0-11; 0=no pain and 10=worst pain imaginable)

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

Data from ClinicalTrials.gov

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