Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

Launched by BEIJING FRIENDSHIP HOSPITAL · Apr 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a condition called degenerative spondylolisthesis (a type of spinal problem) affects the results of a specific surgery called unilateral biportal endoscopy, which is used to treat lumbar spinal stenosis (a narrowing of the spinal canal in the lower back). The goal is to gather more information on how these conditions impact recovery and outcomes after surgery, especially for patients who have not found relief from other treatments.

To be eligible for this study, participants need to be between 50 and 80 years old and diagnosed with lumbar spinal stenosis that affects one or two levels of their spine. They should have experienced significant leg pain or weakness (known as neurogenic intermittent claudication) that hasn’t improved with standard treatments for at least three months. Participants will be closely monitored throughout the study and will need to agree to follow-up assessments to help researchers understand the surgery's effectiveness. It’s important to note that people with certain more severe spinal issues or prior surgeries may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age range: 50-80 years
• • Diagnosis of LSS affecting 1-2 vertebral levels
• • Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
• • Presence of lumbar DS of less than grade II and absence of spine instability
• • Willingness to participate in the study and complete follow-up assessments.
• Exclusion Criteria:
• • Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
• • Evidence of instability at the affected vertebral level (intervertebral angle change \> 15° and/or vertebral translation ≥ 4.5 mm in standing flexion-extension radiographs of the lumbar spine)
• • History of prior surgery at the affected vertebral level
• • Presence of scoliosis with a Cobb angle \>20º
• • Presence of other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
• • Medical disorders that preclude surgical tolerance
• • Participation in other clinical research projects related to the treatment of lumbar spinal stenosis.