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

Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis; Degenerative Spondylolisthesis

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Xiang Li; Phone Number: +86 10 6313 9155; Email: muzixiangxin2022@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Yue Li; Phone Number: +86 10 6313 9006; Email: 13661202501@163.com
      • Principal Investigator: Xiang Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients with LSS who are scheduled to undergo UBE-based decompression, performed by an experienced spine surgeon at Beijing Friendship Hospital, will be recruited from the outpatient clinic for this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	0-100%, the higher the score, the more severe the lumbar spine dysfunction	From enrollment to the end of follow-up at 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
X-ray	Progression of lumbar spondylolisthesis, assessed by postoperative lumbar radiography; (2) Measurement of sagittal translation, segmental angulation, and posterior opening based on postoperative standing flexion-extension radiographs	From enrollment to the end of follow-up at 2 year
Computed tomography (CT) scan	Assessment of bone resection area and preservation rate of the facet joint using postoperative computed tomography (CT) scans	From enrollment to the end of follow-up at 2 year
Magnetic resonance imaging (MRI)	Calculation of the enlargement ratio of the dural sac based on postoperative magnetic resonance imaging (MRI)	From enrollment to the end of follow-up at 2 year
Surgical complication	Any adverse events will be recorded to evaluate the safety of decompression using UBE for LSS with or without DS	From enrollment to the end of follow-up at 2 year
Visual analog scale (VAS) score for lower back pain	0-10, the higher the score, the more severe the pain	From enrollment to the end of follow-up at 2 year
Visual analog scale (VAS) score for leg pain	0-10, the higher the score, the more severe the pain	From enrollment to the end of follow-up at 2 year
Japanese Orthopaedic Association (JOA) score	0-29, the higher the score, the better the lumbar spine function	From enrollment to the end of follow-up at 2 year
Modified MacNab criteria	According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor	From enrollment to the end of follow-up at 2 year
Improvement ratio of Visual analog scale (VAS) score for lower back pain	Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms	From enrollment to the end of follow-up at 2 year
Improvement ratio of Visual analog scale (VAS) score for leg pain	Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms	From enrollment to the end of follow-up at 2 year
Improvement ratio of Japanese Orthopaedic Association (JOA) score	Improvement ratio= (postoperative JOA-preoperative JOA/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of spinal function	From enrollment to the end of follow-up at 2 year
Improvement ratio of Oswestry Disability Index (ODI)	Improvement ratio= (preoperative ODI-postoperative ODI)/preoperative ODI, ranging from 0-100%, the higher the score, the better the improment of symptoms	From enrollment to the end of follow-up at 2 year
Operative time	Time to perform the operation	Immediately after the surgery
Intraoperative blood loss	B、 Blood loss during the surgery	Immediately after the surgery
Postoperative hospital stays	Number of days in hospital after operation	Immediately after the discharge
White blood cell count	White blood cell count of venous blood	From enrollment to 3 days after surgery
Percentage of neutrophils (N%)	The proportion of neutrophils relative to the total white blood cell count	From enrollment to 3 days after surgery
C-reactive protein level	The level of C-reactive protein in blood	From enrollment to 3 days after surgery
Creatine kinase level	The level of creatine kinase in blood	From enrollment to 3 days after surgery
Lactate dehydrogenase level	The level of Lactate dehydrogenase in blood	From enrollment to 3 days after surgery
Myoglobin level	The level of myoglobin in blood	From enrollment to 3 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Spondylolysis; Spondylosis; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 2023-P2-293-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No