Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
Conditions
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
Interventions
None listed
Sponsors
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
| Operative time | Immediately after the surgery | Time to perform the operation |
| Intraoperative blood loss | Immediately after the surgery | B、 Blood loss during the surgery |
| Postoperative hospital stays | Immediately after the discharge | Number of days in hospital after operation |
| 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 |
| 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 |
| 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 |
| White blood cell count | From enrollment to 3 days after surgery | White blood cell count of venous blood |
| Percentage of neutrophils (N%) | From enrollment to 3 days after surgery | The proportion of neutrophils relative to the total white blood cell count |
| C-reactive protein level | From enrollment to 3 days after surgery | The level of C-reactive protein in blood |
| Creatine kinase level | From enrollment to 3 days after surgery | The level of creatine kinase in blood |
| Lactate dehydrogenase level | From enrollment to 3 days after surgery | The level of Lactate dehydrogenase in blood |
| Myoglobin level | From enrollment to 3 days after surgery | The level of myoglobin in blood |
| 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 |
Countries
China
Contacts
Primary ContactXiang Li
Outcome results
None listed