Cervical Foraminal StenosisNCT05270486
Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression
An observational study of Cervical Foraminal Stenosis and Cervical Disc Herniation, run by Centre Hospitalier Régional de la Citadelle.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Foraminal Stenosis, Cervical Disc Herniation
- What is being tested?
- Electromagnetic navigation system
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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
About this study
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).
- Being tested
- Electromagnetic navigation system
- Keywords
- electromagnetic navigation, herniated disc, transforaminal endoscopic lumbar discectomy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic navigation systemProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Group A | group A undergoing TELD (transforaminal endoscopic lumbar discectomy) with electromagnetic navigation system Receives: Procedure: Electromagnetic navigation system | |
| Group B | group B undergoing TELD with X-ray fluoroscopy (gold standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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
Measured: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Foraminal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional de la Citadelle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remacle Thibault, Centre Hospitalier Régional de la Citadelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270486
- Sponsor's protocol ID
- EM Assisted TELD
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression
- ClinicalTrials.gov ID
- NCT05270486
- Acronym / sponsor ID
- EM Assisted TELD
- Keywords
- electromagnetic navigation, herniated disc, transforaminal endoscopic lumbar discectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional de la CitadelleUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Electromagnetic navigation systemgroup A undergoing TELD (transforaminal endoscopic lumbar discectomy) with electromagnetic navigation system |
| Group B | – | –group B undergoing TELD with X-ray fluoroscopy (gold standard) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic navigation systemThe aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH). | Procedure or surgery | Group A |
Primary outcome
Change in Oswestry Disability Index (ODI)
Time frame: 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)
Time frame: 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)
3 secondary outcomes
Back Pain Numerical Rating Score (BPNRS)
Time frame: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
Leg Pain Numerical Rating Score (LPNRS)
Time frame: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
Modified MacNab Criteria
Time frame: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Foraminal Stenosis and Cervical Disc Herniation, run by Centre Hospitalier Régional de la Citadelle.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) (time frame: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.