Lumbar Spinal StenosisNCT06381167
Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis
A study testing Endoscopic Decompressive Laminectomy in people with Lumbar Spinal Stenosis, run by Assiut University.
Trial summary
To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Endoscopic Decompressive Laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acquired degenerative lumbar canal stenosis. Age >40 years. Single or Double level stenosis
Who cannot join
- Post-traumatic lumbar canal stenosis. Previous spine surgery. Multi-level stenosis more than 2 levels. Associated instability e.g. spondylolisthesis. Spinal diseases (e.g., ankylosing spondylitis, infection, spine tumor, fracture, or neurologic disorders).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endoscopic Bi-portal Decompression Versus Microscopic Decompression in Cases of Lumbar Canal Stenosis
To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis.
Read the detailed description
Lumbar canal stenosis is a disease caused by the compression of the dural sac and nerve root due to various factors such as hypertrophy of the ligamentum flavum (LF), facet joint hypertrophy, disc herniation, and spondylolisthesis, resulting in low back pain, leg pain with or without numbness, intermittent claudication, and bladder and bowel dysfunction in which intermittent neurogenic claudication is the main feature (1, 2).
Traditional surgical approaches include open laminotomy decompression, foraminotomy, discectomy, and fusion. Conventional open lumbar decompression has a long history and has the advantages of adequate decompression and clear visualization of neural structures, while surgical invasiveness and extensive stripping of paraspinal muscles and soft tissues may lead to a series of problems such as postoperative low back pain, spinal instability, and prolonged hospital stay and time to return to normal life after the operation (3).
Minimally invasive spine surgery has become increasingly popular in recent years. Unilateral bi-portal endoscopy (UBE) was proposed by Heo in 2017 to treat degenerative lumbar spinal diseases with less damage to the paraspinal muscles (4).
Minimally invasive decompression was introduced as a tissue-sparing alternative and applied to lumbar central stenosis. Minimally invasive decompression revealed good clinical outcomes comparable to those of conventional surgery (5, 6). It also showed a reasonable operative time, shorter hospital stay, and reduced blood loss, time to mobilization, postoperative pain, and narcotic use when compared to that seen with conventional surgery (7).
However, it presents some disadvantages, including poor visualization, difficulty of instrument manipulation, potential to induce inadequate decompression, and longer operative time than other minimally invasive surgeries (8).
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Endoscopic Decompressive Laminectomy
- Keywords
- Endoscopic bi-portal decompression, Microscopic decompression, Lumbar canal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Decompressive LaminectomyProcedure or surgery
Also called Microscopic Decompressive Laminectomy
the patients will undergo block randomization for either endoscopic or microscopic decompression
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic bi-portal decomprssion | Experimental | patients with lumbar canal stenosis will undergo endoscopic decompression Receives: Procedure: Endoscopic Decompressive Laminectomy |
| Microscopic decompression | Experimental | patients with lumbar canal stenosis will undergo microscopic decompression Receives: Procedure: Endoscopic Decompressive Laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index ODI scores for low back pain and neuropathic pain
3,6 and 12-month follow-up after surgery
Measured: one year
Secondary outcomes (3)
visual analog scale (VAS) score for low back and lower extremity radiating pain
3,6 and 12-month follow-up after surgery
Measured: one year
European Quality of Life-5 Dimensions (EQ-5D) score
3,6 and 12-month follow-up after surgery
Measured: one year
painDETECT score
3,6 and 12-month follow-up after surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Soliman Ali Noman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381167
- Sponsor's protocol ID
- Endoscopic decompression
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.
PubMed 31542473Heo DH, Son SK, Eum JH, Park CK. Fully endoscopic lumbar interbody fusion using a percutaneous unilateral biportal endoscopic technique: technical note and preliminary clinical results. Neurosurg Focus. 2017 Aug;43(2):E8. doi: 10.3171/2017.5.FOCUS17146.
PubMed 28760038Wang X, Tian Z, Mansuerjiang M, Younusi A, Xu L, Xiang H, Cao L, Wang C. A single-arm retrospective study of the clinical efficacy of unilateral biportal endoscopic transforaminal lumbar interbody fusion for lumbar spinal stenosis. Front Surg. 2023 Jan 23;9:1062451. doi: 10.3389/fsurg.2022.1062451. eCollection 2022.
PubMed 36756660
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Bi-portal Decompression Versus Microscopic Decompression in Cases of Lumbar Canal Stenosis
- ClinicalTrials.gov ID
- NCT06381167
- Acronym / sponsor ID
- Endoscopic decompression
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Endoscopic bi-portal decompression, Microscopic decompression, Lumbar canal stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Apr 2024 (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.
To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis.
Detailed description
Lumbar canal stenosis is a disease caused by the compression of the dural sac and nerve root due to various factors such as hypertrophy of the ligamentum flavum (LF), facet joint hypertrophy, disc herniation, and spondylolisthesis, resulting in low back pain, leg pain with or without numbness, intermittent claudication, and bladder and bowel dysfunction in which intermittent neurogenic claudication is the main feature (1, 2).
Traditional surgical approaches include open laminotomy decompression, foraminotomy, discectomy, and fusion. Conventional open lumbar decompression has a long history and has the advantages of adequate decompression and clear visualization of neural structures, while surgical invasiveness and extensive stripping of paraspinal muscles and soft tissues may lead to a series of problems such as postoperative low back pain, spinal instability, and prolonged hospital stay and time to return to normal life after the operation (3).
Minimally invasive spine surgery has become increasingly popular in recent years. Unilateral bi-portal endoscopy (UBE) was proposed by Heo in 2017 to treat degenerative lumbar spinal diseases with less damage to the paraspinal muscles (4).
Minimally invasive decompression was introduced as a tissue-sparing alternative and applied to lumbar central stenosis. Minimally invasive decompression revealed good clinical outcomes comparable to those of conventional surgery (5, 6). It also showed a reasonable operative time, shorter hospital stay, and reduced blood loss, time to mobilization, postoperative pain, and narcotic use when compared to that seen with conventional surgery (7).
However, it presents some disadvantages, including poor visualization, difficulty of instrument manipulation, potential to induce inadequate decompression, and longer operative time than other minimally invasive surgeries (8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic bi-portal decomprssion | Experimental | Procedure: Endoscopic Decompressive Laminectomypatients with lumbar canal stenosis will undergo endoscopic decompression |
| Microscopic decompression | Experimental | Procedure: Endoscopic Decompressive Laminectomypatients with lumbar canal stenosis will undergo microscopic decompression |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acquired degenerative lumbar canal stenosis. Age >40 years. Single or Double level stenosis
Key exclusion criteria (1 listed)
- Post-traumatic lumbar canal stenosis. Previous spine surgery. Multi-level stenosis more than 2 levels. Associated instability e.g. spondylolisthesis. Spinal diseases (e.g., ankylosing spondylitis, infection, spine tumor, fracture, or neurologic disorders).
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 |
|---|---|---|
| Endoscopic Decompressive LaminectomyAlso: Microscopic Decompressive Laminectomythe patients will undergo block randomization for either endoscopic or microscopic decompression | Procedure or surgery | Endoscopic bi-portal decomprssion, Microscopic decompression |
Primary outcome
Oswestry Disability Index ODI scores for low back pain and neuropathic pain
Time frame: one year
3,6 and 12-month follow-up after surgery
3 secondary outcomes
visual analog scale (VAS) score for low back and lower extremity radiating pain
Time frame: one year
European Quality of Life-5 Dimensions (EQ-5D) score
Time frame: one year
painDETECT score
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 31542473Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.
- Background: PubMed 28760038Heo DH, Son SK, Eum JH, Park CK. Fully endoscopic lumbar interbody fusion using a percutaneous unilateral biportal endoscopic technique: technical note and preliminary clinical results. Neurosurg Focus. 2017 Aug;43(2):E8. doi: 10.3171/2017.5.FOCUS17146.
- Background: PubMed 36756660Wang X, Tian Z, Mansuerjiang M, Younusi A, Xu L, Xiang H, Cao L, Wang C. A single-arm retrospective study of the clinical efficacy of unilateral biportal endoscopic transforaminal lumbar interbody fusion for lumbar spinal stenosis. Front Surg. 2023 Jan 23;9:1062451. doi: 10.3389/fsurg.2022.1062451. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Decompressive Laminectomy in people with Lumbar Spinal Stenosis, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Soliaman Noman, MSc (00201097038046, alisoliman@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index ODI scores for low back pain and neuropathic pain (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381167, which also lists 3 linked publications.
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 24 Apr 2024.