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

Beijing Friendship Hospital150 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Degenerative Spondylolisthesis Lumbar Spinal Stenosis

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

0-100%, the higher the score, the more severe the lumbar spine dysfunction

Time frame: From enrollment to the end of follow-up at 2 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Xiang Li

CONTACT

+86 10 6313 9155 muzixiangxin2022@163.com

Data from ClinicalTrials.gov

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Time frame: From enrollment to the end of follow-up at 2 year

Operative time

Time to perform the operation

Time frame: Immediately after the surgery

Intraoperative blood loss

B、 Blood loss during the surgery

Time frame: Immediately after the surgery

Postoperative hospital stays

Number of days in hospital after operation

Time frame: Immediately after the discharge

Japanese Orthopaedic Association (JOA) score

0-29, the higher the score, the better the lumbar spine function

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From enrollment to the end of follow-up at 2 year

White blood cell count

White blood cell count of venous blood

Time frame: From enrollment to 3 days after surgery

Percentage of neutrophils (N%)

The proportion of neutrophils relative to the total white blood cell count

Time frame: From enrollment to 3 days after surgery

C-reactive protein level

The level of C-reactive protein in blood

Time frame: From enrollment to 3 days after surgery

Creatine kinase level

The level of creatine kinase in blood

Time frame: From enrollment to 3 days after surgery

Lactate dehydrogenase level

The level of Lactate dehydrogenase in blood

Time frame: From enrollment to 3 days after surgery

Myoglobin level

The level of myoglobin in blood

Time frame: From enrollment to 3 days after surgery