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

Capital Medical University

Status: Enrolling

Conditions: Lumbar Spinal Stenosis; Degenerative Spondylolisthesis

Study type: Observational

Funder types: Other

Identifiers

NCT06394089

2023-P2-293-01

Details and patient eligibility

About

A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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 exceeding 15° 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.

Trial design

240 participants in 2 patient groups

DS Group

Description:

Patients with degenerative spondylolisthesis Meyerding grade Ⅰ (slippage \>3 mm but \<25%) will be identified as having lumbar spinal stenosis combined with degenerative spondylolisthesis and will be allocated to the DS group.

Non-DS Group

Description:

Patients not with degenerative spondylolisthesis will be identified as having lumbar spinal stenosis only and will be allocated to the Non-DS group.