Endoscopic uniportal unilateral laminotomy with bilateral decompression (ULBLD) for lumbar spinal stenosis

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

This study will try a minimally invasive endoscopic uniportal unilateral laminotomy with bilateral decompression (ULBLD) to relieve nerve-compression symptoms in adults with lumbar spinal stenosis who have not improved after at least three months of conservative care.

Quick facts

• Study type: Observational
• Enrollment: 78 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: TecSalud Investigación Clínica (other)
• Locations: 1 site (San Pedro Garza García, Nuevo León)
• Trial ID: NCT07045714 on ClinicalTrials.gov

What this trial studies

This prospective multicenter case series will enroll 78 adults with lumbar spinal stenosis at three Mexican institutions to receive ULBLD using an endoscopic uniportal technique. The procedure uses a single small incision to decompress nerve roots while aiming to spare muscle and soft tissue compared with open laminectomy. Primary outcomes include changes in neurological deficits and disability, and secondary outcomes include hospital stay, operative time, blood loss, and postoperative complications. Patients will be followed after surgery to document clinical outcomes and safety across sites.

Who should consider this trial

Good fit: Adults aged 18 to 74 with radiographic lumbar stenosis grade I–III who have radicular or myelopathic symptoms, have completed at least three months of conservative management, and have chosen ULBLD without prior surgery at the treated levels.

Not a fit: Patients with lumbar instability, prior surgery at the target levels, active infection, certain rheumatologic conditions, congenital spinal malformations, concurrent disc herniation at the treated level, or T2 spinal cord hyperintensity on MRI are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the procedure could relieve nerve-compression symptoms with less tissue damage, lower blood loss, shorter hospital stays, and faster recovery than traditional open surgery.

How similar studies have performed: Other minimally invasive and endoscopic decompression techniques have shown promising results in small series, but uniportal ULBLD is relatively new and lacks large randomized comparisons.

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.

Where this trial is running

San Pedro Garza García, Nuevo León

• Hospital Zambrano Hellion, TecSalud — San Pedro Garza García, Nuevo León, Mexico (RECRUITING)

Study contacts

• Principal investigator: Mario Benvenutti Regato, MD — TecSalud Investigación Clínica
• Study coordinator: Mario Benvenutti Regato, MD

Conditions: Spinal Stenosis Lumbar, Lumbar Spinal Stenosis, Minimally Invasive Surgical Procedures, Endoscopic Spine Surgery, Spinal Degenerative Disease