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

NCT05270486 | Unknown FDA Device

• 1 other identifier: EM Assisted TELD
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cervical Foraminal Stenosis; Cervical Disc Herniation

Keywords

electromagnetic navigation; herniated disc; transforaminal endoscopic lumbar discectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Back Pain Numerical Rating Score (BPNRS)

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

• Leg Pain Numerical Rating Score (LPNRS)

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

• Modified MacNab Criteria

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

Study Arms (2)

Group A

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

Procedure: Electromagnetic navigation system

Group B

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

Interventions

Electromagnetic navigation system PROCEDURE

The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH).

Group A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 consecutive patients, group A undergoing TELD with electromagnetic navigation system vs. group B undergoing TELD with X-ray fluoroscopy (gold standard). Parameters: gender, age, body mass index, neurological examination, comorbidities (diabetes, AHT, depression, smoking, work status, other joint problems), recurrence of disc herniation, follow-up time, pain evaluation on the day before surgery (numerical rating scale), herniation level, type of herniation (disc protrusion, disc prolapsed, disc extrusion or sequestered disc), duration of preoperative back pain/leg pain, use of analgesics (type and duration), preoperative Roland-Morris disability questionnaire, preoperative Oswestry Disability Index.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional de la Citadelle: lead

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD, Neurosurgeon

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: March 8, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 8, 2022

Record last verified: 2022-02