Actively Recruiting

Age: 18Years - 74Years
All Genders
NCT07045714

Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series

Led by TecSalud Investigación Clínica · Updated on 2026-03-04

78

Participants Needed

1

Research Sites

70 weeks

Total Duration

On this page

Sponsors

T

TecSalud Investigación Clínica

Lead Sponsor

T

Tecnologico de Monterrey

Collaborating Sponsor

AI-Summary

What this Trial Is About

Lumbar spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the lumbar spine. While conservative treatments such as physical therapy and pain management can help some patients, others with persistent neurological deficits may require surgical intervention. Traditional surgical approaches, including open laminectomy, have proven effective but carry risks such as extensive muscle damage, considerable blood loss, postoperative spinal instability, and prolonged recovery times. This study evaluates a minimally invasive surgical approach called unilateral laminotomy with bilateral lumbar decompression (ULBLD) using endoscopic uniportal technique as an alternative to traditional methods for patients with lumbar spinal stenosis. The main objective is to assess changes in neurological deficits and disability in patients with lumbar spinal stenosis following this procedure. The study will also document hospitalization duration, surgical time, blood loss, and the incidence of postoperative complications. This multicenter, prospective case series will recruit 78 patients from three medical centers in Mexico. Participants must have symptomatic lumbar spinal stenosis that persists despite at least three months of conservative treatment. Eligible patients will undergo ULBLD using endoscopic uniportal technique, a method that allows precise nerve decompression through a small incision, minimizing damage to surrounding tissues. Standardized clinical assessment tools, including the Japanese Orthopaedic Association (JOA) scale for lumbar disease, Oswestry Disability Index (ODI), and Visual Analog Scale (VAS) for pain, will be used to evaluate outcomes at multiple time points over 12 months. By comparing patients' preoperative and postoperative evaluations, the study aims to determine whether ULBLD using endoscopic uniportal technique effectively improves neurological function and reduces disability while maintaining a favorable safety profile. Findings from this study could lead to a more precise understanding of the impact of ULBLD on disability, pain, and health-related quality of life for patients with lumbar spinal stenosis.

CONDITIONS

Official Title

Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent to participate
  • Be between 18 and 74 years old
  • Have lumbar spinal stenosis grade I-III according to the Lee scale
  • Experience radicular or myelopathic symptoms
  • Have completed at least 3 months of conservative treatment including physical therapy and analgesics
  • Choose to undergo ULBLD using endoscopic uniportal technique for lumbar spinal stenosis
Not Eligible

You will not qualify if you...

  • Unable to read or write
  • Prior lumbar surgeries at the levels to be treated
  • Have infectious symptoms or rheumatologic diseases
  • Have lumbar vertebral instability
  • Have congenital spinal malformations
  • Have disc herniation at the same lumbar level to be operated on
  • Show medullary hyperintensity on T2-weighted MRI at the levels to be treated

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Zambrano Hellion, TecSalud

San Pedro Garza García, Nuevo León, Mexico, 66278

Actively Recruiting

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Research Team

M

Mario Benvenutti Regato, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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