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

NCT07045714 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2026-03-04

No results posted yet for this study

Summary

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

  • Spinal Stenosis Lumbar

Interventions

PROCEDURE

Unilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD)

Unilateral laminotomy with bilateral lumbar decompression (ULBLD) using endoscopic uniportal technique

Sponsors & Collaborators

  • Tecnologico de Monterrey

    collaborator OTHER
  • Centro Medico Nacional Siglo XXI IMSS

    collaborator OTHER
  • Hospital Ángeles Tijuana

    collaborator UNKNOWN
  • Hospital Zambrano Hellion TecSalud, Mexico

    collaborator UNKNOWN
  • TecSalud

    collaborator UNKNOWN
  • TecSalud Investigación Clínica

    lead OTHER

Principal Investigators

  • Mario Benvenutti Regato, MD · TecSalud

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045714 on ClinicalTrials.gov