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.
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.
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.
Patients with lumbar spinal stenosis who continue to experience symptoms despite receiving complete conservative management for at least 3 months and who have chosen to undergo ULBLD using endoscopic uniportal technique will be recruited consecutively. Recruitment will take place at the following healthcare centers: * Centro Médico Zambrano-Hellion, TecSalud (San Pedro Garza García, N.L.) and Clínica Cuauhtémoc y Famosa (Monterrey, N.L.). Patients will be recruited by Dr. Mario Benvenutti Regato, a neurosurgery specialist with over 7 years of experience performing endoscopic spine surgery. * Centro Médico Nacional Siglo XXI (Mexico City)Patients will be recruited by Dr. Félix Domínguez Cortinas, a neurosurgery specialist with over 10 years of experience performing endoscopic spine surgery. * Hospital Ángeles Tijuana (Tijuana, B.C.)Patients will be recruited by Dr. Alfonso García Chávez, a specialist in traumatology and orthopedics with over 10 years of experience
Case-only
Prospective
Unilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD)
Procedure/SurgeryUnilateral laminotomy with bilateral lumbar decompression (ULBLD) using endoscopic uniportal technique
Change in Lumbar Disability (Oswestry Disability Index)
This measure assesses disability related to lumbar pain using the Oswestry Disability Index (ODI), a validated instrument scored from 0% (no disability) to 100% (maximum disability). It quantifies the impact of lumbar pain on daily activities and overall function. Changes in ODI scores over time will reflect the effectiveness of the surgical intervention in reducing pain-related disability.
Change in Neurological Function (Japanese Orthopaedic Association Score for Lumbar Disease)
This measure evaluates neurological function using the Japanese Orthopaedic Association (JOA) scale for lumbar disease. The JOA score, which ranges from -6 to 29 points (where higher scores indicate better neurological function), assesses lumbar pain, lower extremity pain and walking capacity, clinical signs, and restriction in activities of daily living. Improvements in the JOA score following surgery will be used as an indicator of enhanced neurological status.
Change in Back Pain Intensity (Visual Analog Scale - Back)
This measure assesses the intensity of back pain using the Visual Analog Scale (VAS) for back pain, a validated instrument where patients mark their level of pain on a horizontal line from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst imaginable pain". Changes in VAS-back scores over time will reflect the effectiveness of the surgical intervention in reducing back pain intensity.
Change in Lower Extremity Pain Intensity (Visual Analog Scale - Lower Extremity)
This measure assesses the intensity of lower extremity pain using the Visual Analog Scale (VAS) for lower extremity pain. Similar to VAS-back, patients mark their level of pain on a horizontal line from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst imaginable pain". This scale is particularly important for evaluating radicular symptoms commonly associated with lumbar spinal stenosis.
Health-Related Quality of Life (EQ-5D-5L)
The EQ-5D-5L questionnaire consists of two components: a descriptive system and a visual analog scale. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five levels of problems each (no problems, slight problems, moderate problems, severe problems, extreme problems). The visual analog scale records the patient's self-rated health on a vertical scale where the endpoints are labeled 'the best health you can imagine' and 'the worst health you can imagine'. This tool has been validated for the Mexican population and allows derivation of the EQ-5D index value.
Patient Satisfaction with Surgical Outcomes (Modified MacNab Criteria)
This measure evaluates patient satisfaction with respect to functional outcomes obtained after undergoing the surgical procedure using the Modified MacNab Criteria. This scale has been widely used for decades as a tool to assess patient satisfaction and classifies outcomes as: Excellent (no pain or restriction of mobility, return to work and daily activities), Good (occasional non-radicular pain with symptom relief, able to return to work but with restrictions), Fair (some functional improvement, disability and/or inability to return to work), Poor (persists with radicular symptoms, requires new surgical intervention).
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TecSalud Investigación Clínica
Lead sponsor
Tecnologico de Monterrey
Collaborator
Centro Medico Nacional Siglo XXI IMSS
Collaborator
Hospital Ángeles Tijuana
Collaborator
Hospital Zambrano Hellion TecSalud, Mexico
Collaborator
