Open lumbar decompression ± fusion
ProcedureOpen lumbar decompression by laminectomy and transpedicular screw fixation using screws and rods ± interbody cage "device"
NCT Number: NCT06686407
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Lumbar foraminal stenosis decompression will be done using two different techniques:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Open lumbar decompression by laminectomy and transpedicular screw fixation using screws and rods ± interbody cage "device"
A new endoscopic technique that uses a Unilater Biportal Endoscopy for lumbar foraminal decompression
Time frame: Through study completion, an average of 2 years
Time frame: Through study completion, an average of 2 years
Time frame: Through study completion, an average of 2 years
Contact information is provided by the study sponsor or research team.
Alaa Eldeen Mohamed Adam, Assistant lecturer
CONTACT
Radwan Nouby, Professor
CONTACT
Assiut University
Other
Management of Lumbar Foraminal Stenosis Using Unilateral Biportal Endoscopy Versus Conventional Open Spine Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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