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

Centre Hospitalier Régional de la Citadelle

Status: Unknown

Conditions: Cervical Disc Herniation; Cervical Foraminal Stenosis

Treatments: Procedure: Electromagnetic navigation system

Study type: Observational

Funder types: Other

Identifiers

NCT05270486

EM Assisted TELD

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Group A

Description:

group A undergoing TELD (transforaminal endoscopic lumbar discectomy) with electromagnetic navigation system

Treatment:

Procedure: Electromagnetic navigation system

Group B

Description:

group B undergoing TELD with X-ray fluoroscopy (gold standard)