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NCT Number: NCT06686407

Comparative Study Between Lumbar Foraminal Stenosis Treatment Modalities

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open lumbar decompression ± fusion

Procedure

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

A new endoscopic technique that uses a Unilater Biportal Endoscopy for lumbar foraminal decompression

Primary outcomes

  1. Oswestry disability index (ODI)

    Time frame: Through study completion, an average of 2 years

  2. Visual analogue scale (VAS)

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Post operative radiological assessment by MRI on lumbosacral spine.

    Time frame: Through study completion, an average of 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Eldeen Mohamed Adam, Assistant lecturer

CONTACT

[email protected]

+)201008798181

Radwan Nouby, Professor

CONTACT

+0201224480595

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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