RecruitingNCT07045714

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


Sponsor

TecSalud Investigación Clínica

Enrollment

78 participants

Start Date

Feb 25, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Inclusion Criteria6

  • Provision of informed consent to participate in the study.
  • Age ≥18 years and \<75 years.
  • Patients with lumbar spinal stenosis grade I-III according to the Lee scale.
  • Radicular or myelopathic symptoms.
  • Having undergone complete conservative management, including physical therapy and analgesia, for at least 3 months.
  • Patients who have opted for ULBLD using endoscopic uniportal technique for lumbar spinal stenosis.

Exclusion Criteria7

  • Inability to read or write.
  • Prior lumbar surgeries at the levels to be treated.
  • Infectious symptoms or concomitant rheumatologic diseases.
  • Criteria of lumbar vertebral instability.
  • Congenital spinal malformations.
  • Disc herniation at the same lumbar level to be operated on.
  • Medullary hyperintensity on T2-weighted magnetic resonance imaging in the levels to be treated.

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Interventions

PROCEDUREUnilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD)

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


Locations(1)

Hospital Zambrano Hellion, TecSalud

San Pedro Garza García, Nuevo León, Mexico

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NCT07045714


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