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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cervical Foraminal Stenosis, Cervical Disc Herniation

Intervention / Treatment
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* Procedure: Electromagnetic navigation system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>group A undergoing TELD (transforaminal endoscopic lumbar discectomy) with electromagnetic navigation system | Procedure: Electromagnetic navigation system<br>* The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH).<br>|
| Group B<br>group B undergoing TELD with X-ray fluoroscopy (gold standard) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | 
| Modified MacNab Criteria | Patient is asked about his well being and has to choose between: Excellent: No pain, No restriction of mobility, Return to normal work and level of activity Good: Occasional nonradicular pain, Relief of presenting symptoms, Able to return to modified work Fair: Some improved functional capacity, Still handicapped and/or unemployed Poor: Continued objective symptoms of root involvement, Additional operative intervention needed at index level irrespective of length of postoperative follow-up | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electromagnetic navigation, herniated disc, transforaminal endoscopic lumbar discectomy