Lumbar Foraminal StenosisNCT06686407
Comparative Study Between Lumbar Foraminal Stenosis Treatment Modalities
A study testing Open lumbar decompression ± fusion and Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device" in people with Lumbar Foraminal Stenosis, run by Assiut University.
Trial summary
The goal of this clinical trial is to compare the clinical and radiological outcome of two different interventional techniques in lumbar foraminal stenosis decompression. The main questions it aims to answer are: Does minimally invasive techniques give better results than conventional techniques? Participants will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Foraminal Stenosis
- What is being tested?
- Open lumbar decompression ± fusion and Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Patients with degenerative lumbar foraminal stenosis, diagnosed in outpatient clinic.
- Patients (age >18 )
Who cannot join
- Deformity.
- Infection of vertebrae.
- Tumor of vertebrae.
- Instability.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Radwan Nouby, Professor contact
About this study
Official title: Management of Lumbar Foraminal Stenosis Using Unilateral Biportal Endoscopy Versus Conventional Open Spine Surgery
The goal of this clinical trial is to compare the clinical and radiological outcome of two different interventional techniques in lumbar foraminal stenosis decompression. The main questions it aims to answer are:
Does minimally invasive techniques give better results than conventional techniques?
Participants will:
Undergo minimally invasive intervention using unilateral biportal endoscopy for lumbar foraminal stenosis decompression Undergo lumbar fusion for lumbar foraminal stenosis decompression Keep a diary of their symptoms and improvement of these symptoms
Read the detailed description
Lumbar foraminal stenosis decompression will be done using two different techniques:
- Conventional Open Lumbar fusion By laminectomy and facetectomy and fixation with screws and rods ± interbody cage
- Minimally invasive (Unilateral Biportal Endoscopy) Basic spine surgery instruments, 0° and 30° angled 4-mm diameter endoscopes commonly used in joint arthroscopic surgery, a radiofrequency catheter, Arthroscopic burr, and a shaver.
Surgical approach to the foraminal area Two portals are created to perform this surgery. Water is infused through the endoscope through the viewing portal, and the working portal had an additional purpose as a portal for water outflow. The proximal and distal portals are created 2 cm lateral from the pedicle level on the C-arm anteroposterior image. Each incision for the portals is 0.8 cm in length, which is adequate for instrument and endoscope insertion. For the left side foramen, the proximal and distal portals are used as the viewing and working portals, respectively, and vice versa for the right foramen. After the endoscope insertion through the viewing portal, we secure a space for the lower transverse process around the lateral surface of the facet joint. A radiofrequency catheter or a shaver is used to secure the space, and a radiofrequency catheter is used to control active bleeding.
Decompression of foraminal stenosis After a sufficient working space is obtained, the cranial 50% of the superior articular process of the thickened facet joint is removed using an arthroscopic burr or an osteotome. After removing the superior articular process, the ligamentum flavum around the foramen is removed using a curette and a Kerrison punch. After completion of flavectomy, nerve root and epidural fat are identified. If herniated disc material is found preoperatively, additional discectomy is performed usually from the axilla of the root. Surgery is confirmed to be completed after achieving an amount of free space concordant with the diameter of the nerve root in the foraminal zone, and then a drain tube is inserted.
- Conditions
- Lumbar Foraminal Stenosis
- Being tested
- Open lumbar decompression ± fusion, Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open lumbar decompression ± fusionProcedure or surgery
Open lumbar decompression by laminectomy and transpedicular screw fixation using screws and rods ± interbody cage "device"
Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device"Procedure or surgery
A new endoscopic technique that uses a Unilater Biportal Endoscopy for lumbar foraminal decompression
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Procedure: Open lumbar decompression ± fusion |
| Group 2 | Experimental | Not described Receives: Procedure: Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index (ODI)
Measured: Through study completion, an average of 2 years
Visual analogue scale (VAS)
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Post operative radiological assessment by MRI on lumbosacral spine.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study startNov 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Lumbar Foraminal 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eldeen Mohamed Oreaby Adam, Assiut University
- Investigators
- Wael Mohamed Ali, Assistant Professor, Study director, Assiut UniversityAhmed Hussein Mohamed, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686407
- Sponsor's protocol ID
- Lumbar Foraminal Stenosis
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soliman HM. Irrigation endoscopic decompressive laminotomy. A new endoscopic approach for spinal stenosis decompression. Spine J. 2015 Oct 1;15(10):2282-9. doi: 10.1016/j.spinee.2015.07.009. Epub 2015 Jul 10.
PubMed 26165475Choi DJ, Jung JT, Lee SJ, Kim YS, Jang HJ, Yoo B. Biportal Endoscopic Spinal Surgery for Recurrent Lumbar Disc Herniations. Clin Orthop Surg. 2016 Sep;8(3):325-9. doi: 10.4055/cios.2016.8.3.325. Epub 2016 Aug 10.
PubMed 27583117Storzer B, Schnake KJ. Microscopic bilateral decompression by unilateral approach in spinal stenosis. Eur Spine J. 2016 Aug;25 Suppl 2:270-1. doi: 10.1007/s00586-016-4479-3. No abstract available.
PubMed 26931328Poletti CE. Central lumbar stenosis caused by ligamentum flavum: unilateral laminotomy for bilateral ligamentectomy: preliminary report of two cases. Neurosurgery. 1995 Aug;37(2):343-7. doi: 10.1227/00006123-199508000-00025.
PubMed 7477792Guha D, Heary RF, Shamji MF. Iatrogenic spondylolisthesis following laminectomy for degenerative lumbar stenosis: systematic review and current concepts. Neurosurg Focus. 2015 Oct;39(4):E9. doi: 10.3171/2015.7.FOCUS15259.
PubMed 26424349Kunogi J, Hasue M. Diagnosis and operative treatment of intraforaminal and extraforaminal nerve root compression. Spine (Phila Pa 1976). 1991 Nov;16(11):1312-20. doi: 10.1097/00007632-199111000-00012.
PubMed 1750006Lee S, Lee JW, Yeom JS, Kim KJ, Kim HJ, Chung SK, Kang HS. A practical MRI grading system for lumbar foraminal stenosis. AJR Am J Roentgenol. 2010 Apr;194(4):1095-8. doi: 10.2214/AJR.09.2772.
PubMed 20308517Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Hwa Eum J, Hwa Heo D, Son SK, Park CK. Percutaneous biportal endoscopic decompression for lumbar spinal stenosis: a technical note and preliminary clinical results. J Neurosurg Spine. 2016 Apr;24(4):602-7. doi: 10.3171/2015.7.SPINE15304. Epub 2016 Jan 1.
PubMed 26722954Bresnahan LE, Smith JS, Ogden AT, Quinn S, Cybulski GR, Simonian N, Natarajan RN, Fessler RD, Fessler RG. Assessment of Paraspinal Muscle Cross-sectional Area After Lumbar Decompression: Minimally Invasive Versus Open Approaches. Clin Spine Surg. 2017 Apr;30(3):E162-E168. doi: 10.1097/BSD.0000000000000038.
PubMed 28323694Kim HJ, Jeong JH, Cho HG, Chang BS, Lee CK, Yeom JS. Comparative observational study of surgical outcomes of lumbar foraminal stenosis using minimally invasive microsurgical extraforaminal decompression alone versus posterior lumbar interbody fusion: a prospective cohort study. Eur Spine J. 2015 Feb;24(2):388-95. doi: 10.1007/s00586-014-3592-4. Epub 2014 Sep 25.
PubMed 25253301Hallett A, Huntley JS, Gibson JN. Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1375-80. doi: 10.1097/BRS.0b013e318064520f.
PubMed 17545903Chang SB, Lee SH, Ahn Y, Kim JM. Risk factor for unsatisfactory outcome after lumbar foraminal and far lateral microdecompression. Spine (Phila Pa 1976). 2006 May 1;31(10):1163-7. doi: 10.1097/01.brs.0000216431.69359.91.
PubMed 16648754Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.
PubMed 21311394Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
PubMed 18287602
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Lumbar Foraminal Stenosis Using Unilateral Biportal Endoscopy Versus Conventional Open Spine Surgery
- ClinicalTrials.gov ID
- NCT06686407
- Acronym / sponsor ID
- Lumbar Foraminal Stenosis
- Conditions
- Lumbar Foraminal Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Nov 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.
The goal of this clinical trial is to compare the clinical and radiological outcome of two different interventional techniques in lumbar foraminal stenosis decompression. The main questions it aims to answer are:
Does minimally invasive techniques give better results than conventional techniques?
Participants will:
Undergo minimally invasive intervention using unilateral biportal endoscopy for lumbar foraminal stenosis decompression Undergo lumbar fusion for lumbar foraminal stenosis decompression Keep a diary of their symptoms and improvement of these symptoms
Detailed description
Lumbar foraminal stenosis decompression will be done using two different techniques:
- Conventional Open Lumbar fusion By laminectomy and facetectomy and fixation with screws and rods ± interbody cage
- Minimally invasive (Unilateral Biportal Endoscopy) Basic spine surgery instruments, 0° and 30° angled 4-mm diameter endoscopes commonly used in joint arthroscopic surgery, a radiofrequency catheter, Arthroscopic burr, and a shaver.
Surgical approach to the foraminal area Two portals are created to perform this surgery. Water is infused through the endoscope through the viewing portal, and the working portal had an additional purpose as a portal for water outflow. The proximal and distal portals are created 2 cm lateral from the pedicle level on the C-arm anteroposterior image. Each incision for the portals is 0.8 cm in length, which is adequate for instrument and endoscope insertion. For the left side foramen, the proximal and distal portals are used as the viewing and working portals, respectively, and vice versa for the right foramen. After the endoscope insertion through the viewing portal, we secure a space for the lower transverse process around the lateral surface of the facet joint. A radiofrequency catheter or a shaver is used to secure the space, and a radiofrequency catheter is used to control active bleeding.
Decompression of foraminal stenosis After a sufficient working space is obtained, the cranial 50% of the superior articular process of the thickened facet joint is removed using an arthroscopic burr or an osteotome. After removing the superior articular process, the ligamentum flavum around the foramen is removed using a curette and a Kerrison punch. After completion of flavectomy, nerve root and epidural fat are identified. If herniated disc material is found preoperatively, additional discectomy is performed usually from the axilla of the root. Surgery is confirmed to be completed after achieving an amount of free space concordant with the diameter of the nerve root in the foraminal zone, and then a drain tube is inserted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Open lumbar decompression ± fusion |
| Group 2 | Experimental | Procedure: Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All Patients with degenerative lumbar foraminal stenosis, diagnosed in outpatient clinic.
- Patients (age >18 )
Key exclusion criteria (4 listed)
- Deformity.
- Infection of vertebrae.
- Tumor of vertebrae.
- Instability.
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 |
|---|---|---|
| Open lumbar decompression ± fusionOpen lumbar decompression by laminectomy and transpedicular screw fixation using screws and rods ± interbody cage "device" | Procedure or surgery | Group 1 |
| Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device"A new endoscopic technique that uses a Unilater Biportal Endoscopy for lumbar foraminal decompression | Procedure or surgery | Group 2 |
Primary outcome
Oswestry disability index (ODI)
Time frame: Through study completion, an average of 2 years
Visual analogue scale (VAS)
Time frame: Through study completion, an average of 2 years
1 secondary outcome
Post operative radiological assessment by MRI on lumbosacral spine.
Time frame: Through study completion, an average of 2 years
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 13 Nov 2024.
- Background: PubMed 26165475Soliman HM. Irrigation endoscopic decompressive laminotomy. A new endoscopic approach for spinal stenosis decompression. Spine J. 2015 Oct 1;15(10):2282-9. doi: 10.1016/j.spinee.2015.07.009. Epub 2015 Jul 10.
- Background: PubMed 27583117Choi DJ, Jung JT, Lee SJ, Kim YS, Jang HJ, Yoo B. Biportal Endoscopic Spinal Surgery for Recurrent Lumbar Disc Herniations. Clin Orthop Surg. 2016 Sep;8(3):325-9. doi: 10.4055/cios.2016.8.3.325. Epub 2016 Aug 10.
- Background: PubMed 26931328Storzer B, Schnake KJ. Microscopic bilateral decompression by unilateral approach in spinal stenosis. Eur Spine J. 2016 Aug;25 Suppl 2:270-1. doi: 10.1007/s00586-016-4479-3. No abstract available.
- Background: PubMed 7477792Poletti CE. Central lumbar stenosis caused by ligamentum flavum: unilateral laminotomy for bilateral ligamentectomy: preliminary report of two cases. Neurosurgery. 1995 Aug;37(2):343-7. doi: 10.1227/00006123-199508000-00025.
- Background: PubMed 26424349Guha D, Heary RF, Shamji MF. Iatrogenic spondylolisthesis following laminectomy for degenerative lumbar stenosis: systematic review and current concepts. Neurosurg Focus. 2015 Oct;39(4):E9. doi: 10.3171/2015.7.FOCUS15259.
- Results publication: PubMed 1750006Kunogi J, Hasue M. Diagnosis and operative treatment of intraforaminal and extraforaminal nerve root compression. Spine (Phila Pa 1976). 1991 Nov;16(11):1312-20. doi: 10.1097/00007632-199111000-00012.
- Results publication: PubMed 20308517Lee S, Lee JW, Yeom JS, Kim KJ, Kim HJ, Chung SK, Kang HS. A practical MRI grading system for lumbar foraminal stenosis. AJR Am J Roentgenol. 2010 Apr;194(4):1095-8. doi: 10.2214/AJR.09.2772.
- Results publication: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Results publication: PubMed 26722954Hwa Eum J, Hwa Heo D, Son SK, Park CK. Percutaneous biportal endoscopic decompression for lumbar spinal stenosis: a technical note and preliminary clinical results. J Neurosurg Spine. 2016 Apr;24(4):602-7. doi: 10.3171/2015.7.SPINE15304. Epub 2016 Jan 1.
- Results publication: PubMed 28323694Bresnahan LE, Smith JS, Ogden AT, Quinn S, Cybulski GR, Simonian N, Natarajan RN, Fessler RD, Fessler RG. Assessment of Paraspinal Muscle Cross-sectional Area After Lumbar Decompression: Minimally Invasive Versus Open Approaches. Clin Spine Surg. 2017 Apr;30(3):E162-E168. doi: 10.1097/BSD.0000000000000038.
- Results publication: PubMed 25253301Kim HJ, Jeong JH, Cho HG, Chang BS, Lee CK, Yeom JS. Comparative observational study of surgical outcomes of lumbar foraminal stenosis using minimally invasive microsurgical extraforaminal decompression alone versus posterior lumbar interbody fusion: a prospective cohort study. Eur Spine J. 2015 Feb;24(2):388-95. doi: 10.1007/s00586-014-3592-4. Epub 2014 Sep 25.
- Results publication: PubMed 17545903Hallett A, Huntley JS, Gibson JN. Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1375-80. doi: 10.1097/BRS.0b013e318064520f.
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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.
Radwan Nouby, Professor contact
Wael Mohamed Ali, Assistant Professor study director
Assiut University
Ahmed Hussein Mohamed, Lecturer study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Open lumbar decompression ± fusion and Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device" in people with Lumbar Foraminal 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 2 inclusion and 4 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 13 Nov 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 Alaa Eldeen Mohamed Adam, Assistant lecturer (+)201008798181, alaaoreaby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability index (ODI) (time frame: Through study completion, an average of 2 years). 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?
On the ClinicalTrials.gov record for NCT06686407, which also lists 20 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 13 Nov 2024.