Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

NCT06381167 | Not Yet Recruiting

• 1 other identifier: Endoscopic decompression
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis.

Conditions

Lumbar Spinal Stenosis

Keywords

Endoscopic bi-portal decompression; Microscopic decompression; Lumbar canal stenosis

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index ODI scores for low back pain and neuropathic pain

  3,6 and 12-month follow-up after surgery

  one year

Secondary Outcomes (3)

• visual analog scale (VAS) score for low back and lower extremity radiating pain

  one year

• European Quality of Life-5 Dimensions (EQ-5D) score

  one year

• painDETECT score

  one year

Study Arms (2)

Endoscopic bi-portal decomprssion

EXPERIMENTAL

patients with lumbar canal stenosis will undergo endoscopic decompression

Procedure: Endoscopic Decompressive Laminectomy

Microscopic decompression

EXPERIMENTAL

patients with lumbar canal stenosis will undergo microscopic decompression

Procedure: Endoscopic Decompressive Laminectomy

Interventions

Endoscopic Decompressive Laminectomy PROCEDURE

the patients will undergo block randomization for either endoscopic or microscopic decompression

Also known as: Microscopic Decompressive Laminectomy

Endoscopic bi-portal decomprssion; Microscopic decompression

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acquired degenerative lumbar canal stenosis. Age \>40 years. Single or Double level stenosis

You may not qualify if:

• Post-traumatic lumbar canal stenosis. Previous spine surgery. Multi-level stenosis more than 2 levels. Associated instability e.g. spondylolisthesis. Spinal diseases (e.g., ankylosing spondylitis, infection, spine tumor, fracture, or neurologic disorders).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.

  PMID: 31542473 BACKGROUND

• Heo DH, Son SK, Eum JH, Park CK. Fully endoscopic lumbar interbody fusion using a percutaneous unilateral biportal endoscopic technique: technical note and preliminary clinical results. Neurosurg Focus. 2017 Aug;43(2):E8. doi: 10.3171/2017.5.FOCUS17146.

  PMID: 28760038 BACKGROUND

• Wang X, Tian Z, Mansuerjiang M, Younusi A, Xu L, Xiang H, Cao L, Wang C. A single-arm retrospective study of the clinical efficacy of unilateral biportal endoscopic transforaminal lumbar interbody fusion for lumbar spinal stenosis. Front Surg. 2023 Jan 23;9:1062451. doi: 10.3389/fsurg.2022.1062451. eCollection 2022.

  PMID: 36756660 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Ali Soliaman Noman, MSc

CONTACT

00201097038046; alisoliman@med.nvu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share