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Not yet recruiting NCT06381167

Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

No phase Interventional Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Decompressive Laminectomy.
Who it may be relevant to
Registry conditions: Lumbar Spinal Stenosis. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Endoscopic Bi-portal Decompression Versus Microscopic Decompression in Cases of Lumbar Canal Stenosis

Overview

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

Detailed description

Lumbar canal stenosis is a disease caused by the compression of the dural sac and nerve root due to various factors such as hypertrophy of the ligamentum flavum (LF), facet joint hypertrophy, disc herniation, and spondylolisthesis, resulting in low back pain, leg pain with or without numbness, intermittent claudication, and bladder and bowel dysfunction in which intermittent neurogenic claudication is the main feature (1, 2).

Traditional surgical approaches include open laminotomy decompression, foraminotomy, discectomy, and fusion. Conventional open lumbar decompression has a long history and has the advantages of adequate decompression and clear visualization of neural structures, while surgical invasiveness and extensive stripping of paraspinal muscles and soft tissues may lead to a series of problems such as postoperative low back pain, spinal instability, and prolonged hospital stay and time to return to normal life after the operation (3).

Minimally invasive spine surgery has become increasingly popular in recent years. Unilateral bi-portal endoscopy (UBE) was proposed by Heo in 2017 to treat degenerative lumbar spinal diseases with less damage to the paraspinal muscles (4).

Minimally invasive decompression was introduced as a tissue-sparing alternative and applied to lumbar central stenosis. Minimally invasive decompression revealed good clinical outcomes comparable to those of conventional surgery (5, 6). It also showed a reasonable operative time, shorter hospital stay, and reduced blood loss, time to mobilization, postoperative pain, and narcotic use when compared to that seen with conventional surgery (7).

However, it presents some disadvantages, including poor visualization, difficulty of instrument manipulation, potential to induce inadequate decompression, and longer operative time than other minimally invasive surgeries (8).

Interventions

  • Procedure Endoscopic Decompressive Laminectomy
    the patients will undergo block randomization for either endoscopic or microscopic decompression

Primary outcome measures

  • Oswestry Disability Index ODI scores for low back pain and neuropathic pain [Time frame: one year]
Secondary outcome measures (3)
  • visual analog scale (VAS) score for low back and lower extremity radiating pain [Time frame: one year]
  • European Quality of Life-5 Dimensions (EQ-5D) score [Time frame: one year]
  • painDETECT score [Time frame: one year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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).

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
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT06381167 · Endoscopic decompression

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗