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

Cervical Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05270486
• Other study ID #: EM Assisted TELD
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Régional de la Citadelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Cervical Foraminal Stenosis
• Hernia

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional de la Citadelle

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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