Comparative Study Between Lumbar Foraminal Stenosis Treatment Modalities

Official title

Management of Lumbar Foraminal Stenosis Using Unilateral Biportal Endoscopy Versus Conventional Open Spine Surgery

Overview

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:

1. Conventional Open Lumbar fusion By laminectomy and facetectomy and fixation with screws and rods ± interbody cage 2. 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.

Interventions

• Procedure Open lumbar decompression ± fusion
  Open lumbar decompression by laminectomy and transpedicular screw fixation using screws and rods ± interbody cage "device"
• Procedure Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device"
  A new endoscopic technique that uses a Unilater Biportal Endoscopy for lumbar foraminal decompression

Primary outcome measures

• 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]

Secondary outcome measures (1)

• Post operative radiological assessment by MRI on lumbosacral spine. [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

• All Patients with degenerative lumbar foraminal stenosis, diagnosed in outpatient clinic.
• Patients (age >18 )

Exclusion criteria

• Deformity.
• Infection of vertebrae.
• Tumor of vertebrae.
• Instability.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 26165475
• Choi 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. PMID 27583117
• Storzer 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. PMID 26931328
• Poletti 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. PMID 7477792
• Guha 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. PMID 26424349
• Kunogi 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. PMID 1750006
• Lee 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. PMID 20308517
• Faul 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. PMID 17695343

Identifiers

NCT: NCT06686407 · Lumbar Foraminal Stenosis

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗