NCT07045714 Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series
| NCT ID | NCT07045714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TecSalud Investigación Clínica |
| Condition | Spinal Stenosis Lumbar |
| Study Type | OBSERVATIONAL |
| Enrollment | 78 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 78 participants in total. It began in 2026-02-25 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Mario Benvenutti Regato, MD
PRINCIPAL INVESTIGATOR
TecSalud Investigación Clínica
Frequently Asked Questions
Who can join the NCT07045714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Spinal Stenosis Lumbar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07045714 currently recruiting?
Yes, NCT07045714 is actively recruiting participants. Contact the research team at mbenreg@tec.mx for enrollment information.
Where is the NCT07045714 trial being conducted?
This trial is being conducted at San Pedro Garza García, Mexico.
Who is sponsoring the NCT07045714 clinical trial?
NCT07045714 is sponsored by TecSalud Investigación Clínica. The principal investigator is Mario Benvenutti Regato, MD at TecSalud Investigación Clínica. The trial plans to enroll 78 participants.