Cervical Disc Herniation, Cervical Foraminal Stenosis
Conditions
Keywords
electromagnetic navigation, herniated disc, transforaminal endoscopic lumbar discectomy
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 treating lumbar disc herniation (LDH).
Interventions
PROCEDUREElectromagnetic 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).
Sponsors
Centre Hospitalier Régional de la Citadelle
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | 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. |
| Change in Roland Morris Disability Questionnaire (RMDQ) | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back Pain Numerical Rating Score (BPNRS) | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | Patient is asked to rate his pain between 11 points (0-11; 0=no pain and 10=worst pain imaginable) |
| Leg Pain Numerical Rating Score (LPNRS) | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | Patient is asked to rate his pain between 11 points (0-11; 0=no pain and 10=worst pain imaginable) |
| Modified MacNab Criteria | Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively | 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 |
Outcome results
None listed