Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381167
• Other study ID #: Endoscopic decompression
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Ali Soliaman Noman, MSc
• Phone: 00201097038046
• Email: alisoliman[@]med.nvu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index ODI scores for low back pain and neuropathic pain	3,6 and 12-month follow-up after surgery	one year
Secondary	visual analog scale (VAS) score for low back and lower extremity radiating pain	3,6 and 12-month follow-up after surgery	one year
Secondary	European Quality of Life-5 Dimensions (EQ-5D) score	3,6 and 12-month follow-up after surgery	one year
Secondary	painDETECT score	3,6 and 12-month follow-up after surgery	one year