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

NCT07045714 | Recruiting

• 1 other identifier: MELD-1
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis Lumbar

Keywords

Lumbar Spinal Stenosis; Minimally Invasive Surgical Procedures; Endoscopic Spine Surgery; Spinal Degenerative Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

• 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.

  Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

Secondary Outcomes (8)

• Change in Back Pain Intensity (Visual Analog Scale - Back)

  Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

• Change in Lower Extremity Pain Intensity (Visual Analog Scale - Lower Extremity)

  Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

• Health-Related Quality of Life (EQ-5D-5L)

  Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

• Patient Satisfaction with Surgical Outcomes (Modified MacNab Criteria)

  1 month, 3 months, 6 months, and 12 months postoperatively.

• Duration of Hospitalization

  Measured during the index hospitalization.

Study Arms (1)

Lumbar Spinal Stenosis Cases

Patients diagnosed with lumbar spinal stenosis who exhibit persistent neurological deficits and pain despite receiving at least three months of conservative treatment. All participants have elected to undergo ULBLD using endoscopic uniportal technique. They are being prospectively followed to evaluate improvements in neurological function and reductions in pain-related disability, as well as to document perioperative outcomes including surgical time, blood loss, hospital stay, and complications.

Procedure: Unilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD)

Interventions

Unilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD) PROCEDURE

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

Lumbar Spinal Stenosis Cases

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tecnologico de Monterrey: collaborator
• Hospital Ángeles Tijuana: collaborator
• Hospital Zambrano Hellion TecSalud, Mexico: collaborator
• TecSalud: collaborator
• TecSalud Investigación Clínica: lead
• Centro Medico Nacional Siglo XXI IMSS: collaborator

Study Sites (1)

Hospital Zambrano Hellion, TecSalud

San Pedro Garza García, Nuevo León, 66278, Mexico

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mario Benvenutti Regato, MD

  TecSalud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Benvenutti Regato, MD

CONTACT

(+52) 81 8888 0675; mbenreg@tec.mx

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)