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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Disc Herniation; Cervical Foraminal Stenosis
• Intervention / Treatment: Procedure: Electromagnetic navigation system

• Study Type: Observational
• Enrollment (Anticipated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; group A undergoing TELD (transforaminal endoscopic lumbar discectomy) with electromagnetic navigation system	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).
Group B; group B undergoing TELD with X-ray fluoroscopy (gold standard)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional de la Citadelle

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: herniated disc; electromagnetic navigation; transforaminal endoscopic lumbar discectomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: EM Assisted TELD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No