Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Recruiting
NCT Number: NCT06394089
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study 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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Oswestry Disability Index (ODI)
Time frame: 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 outcomes
-
X-ray
Time frame: 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
-
Computed tomography (CT) scan
Time frame: 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
-
Magnetic resonance imaging (MRI)
Time frame: 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)
-
Surgical complication
Time frame: 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
-
Visual analog scale (VAS) score for lower back pain
Time frame: 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
Time frame: From enrollment to the end of follow-up at 2 year
0-10, the higher the score, the more severe the pain
-
Operative time
Time frame: Immediately after the surgery
Time to perform the operation
-
Intraoperative blood loss
Time frame: Immediately after the surgery
B、 Blood loss during the surgery
-
Postoperative hospital stays
Time frame: Immediately after the discharge
Number of days in hospital after operation
-
Japanese Orthopaedic Association (JOA) score
Time frame: 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
Time frame: 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
Time frame: 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 Visual analog scale (VAS) score for leg pain
Time frame: 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
Time frame: 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)
Time frame: 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
-
White blood cell count
Time frame: From enrollment to 3 days after surgery
White blood cell count of venous blood
-
Percentage of neutrophils (N%)
Time frame: From enrollment to 3 days after surgery
The proportion of neutrophils relative to the total white blood cell count
-
C-reactive protein level
Time frame: From enrollment to 3 days after surgery
The level of C-reactive protein in blood
-
Creatine kinase level
Time frame: From enrollment to 3 days after surgery
The level of creatine kinase in blood
-
Lactate dehydrogenase level
Time frame: From enrollment to 3 days after surgery
The level of Lactate dehydrogenase in blood
-
Myoglobin level
Time frame: From enrollment to 3 days after surgery
The level of myoglobin in blood
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Beijing Friendship Hospital
Other
Registry information
Official study title
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 1, 2024
- Registry last updated
- Jun 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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