Comparative Study Between Lumbar Foraminal Stenosis Treatment Modalities

NCT06686407 | Not Yet Recruiting

• 1 other identifier: Lumbar Foraminal Stenosis
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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: 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

Conditions

Lumbar Foraminal Stenosis

Outcome Measures

Primary Outcomes (2)

• Oswestry disability index (ODI)

  Through study completion, an average of 2 years

• Visual analogue scale (VAS)

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• Post operative radiological assessment by MRI on lumbosacral spine.

  Through study completion, an average of 2 years

Study Arms (2)

Group 1

EXPERIMENTAL

Procedure: Open lumbar decompression ± fusion

Group 2

EXPERIMENTAL

Procedure: Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device"

Interventions

Open lumbar decompression ± fusion PROCEDURE

Open lumbar decompression by laminectomy and transpedicular screw fixation using screws and rods ± interbody cage "device"

Group 1

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (20)

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  PMID: 27583117 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bresnahan 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.

  PMID: 28323694 BACKGROUND

• 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 BACKGROUND

• Kim 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.

  PMID: 25253301 BACKGROUND

• Hallett 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.

  PMID: 17545903 BACKGROUND

• Chang 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.

  PMID: 16648754 BACKGROUND

• Kovacs 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.

  PMID: 21311394 BACKGROUND

• Weinstein 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.

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  PMID: 10703115 BACKGROUND

Study Officials

• Wael Mohamed Ali, Assistant Professor

  Assiut University

  STUDY DIRECTOR

• Ahmed Hussein Mohamed, Lecturer

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Alaa Eldeen Mohamed Adam, Assistant lecturer

CONTACT

+)201008798181; alaaoreaby@gmail.com

Radwan Nouby, Professor

CONTACT

+0201224480595

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 13, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11