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

Recruiting

• Conditions: Lumbar Spinal Stenosis; Degenerative Spondylolisthesis

• Registration Number: NCT06394089
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-05-01
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
X-ray	From enrollment to the end of follow-up at 2 year	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
Surgical complication	From enrollment to the end of follow-up at 2 year	Any adverse events will be recorded to evaluate the safety of decompression using UBE for LSS with or without DS
Computed tomography (CT) scan	From enrollment to the end of follow-up at 2 year	Assessment of bone resection area and preservation rate of the facet joint using postoperative computed tomography (CT) scans
Visual analog scale (VAS) score for lower back pain	From enrollment to the end of follow-up at 2 year	0-10, the higher the score, the more severe the pain
Visual analog scale (VAS) score for leg pain	From enrollment to the end of follow-up at 2 year	0-10, the higher the score, the more severe the pain
Magnetic resonance imaging (MRI)	From enrollment to the end of follow-up at 2 year	Calculation of the enlargement ratio of the dural sac based on postoperative magnetic resonance imaging (MRI)
Erythrocyte sedimentation rate (ESR)	From enrollment to the end of follow-up at 2 year
Operative time	Immediately after the surgery
Postoperative hospital stays	Immediately after the discharge
Creatine kinase (CK)	From enrollment to the end of follow-up at 2 year
Japanese Orthopaedic Association (JOA) score	From enrollment to the end of follow-up at 2 year	0-29, the higher the score, the better the lumbar spine function
Modified MacNab criteria	From enrollment to the end of follow-up at 2 year	According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor
Improvement ratio of Visual analog scale (VAS) score for lower back pain	From enrollment to the end of follow-up at 2 year	Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms
Intraoperative blood loss	Immediately after the surgery
Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey	From enrollment to the end of follow-up at 2 year	0-100 points, with higher scores indicating better physical health-related quality of life
Improvement ratio of Visual analog scale (VAS) score for leg pain	From enrollment to the end of follow-up at 2 year	Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms
Improvement ratio of Japanese Orthopaedic Association (JOA) score	From enrollment to the end of follow-up at 2 year	Improvement ratio= (postoperative JOA-preoperative JOA/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of spinal function
Improvement ratio of Oswestry Disability Index (ODI)	From enrollment to the end of follow-up at 2 year	Improvement ratio= (preoperative ODI-postoperative ODI)/preoperative ODI, ranging from 0-100%, the higher the score, the better the improment of symptoms

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China