Lumbar Spinal Stenosis
Conditions
Brief summary
A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS).
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
Inclusion criteria
* Age range: 50-80 years * Diagnosed with LSS of 1-2 response levels * The predominant manifestation is neurogenic intermittent claudication, and conservative treatment has been ineffective for at least 3 months * Degenerative lumbar spondylolisthesis of less than I degree or without spine instability * Patients agree to participate in the study and are willing to complete the follow-up
Exclusion criteria
* Isthmic lumbar spondylolisthesis or degenerative lumbar spondylolisthesis of greater than I degree * Instability at the response level * Prior surgical history at the response level * Scoliosis with Cobb angle >20 degrees * Other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others) * Patients with medical disorders who are unable to tolerate surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | From enrollment to the end of follow-up at 1 year | 0-100%, the higher the score, the more severe the lumbar spine dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Computed tomography (CT) scans | From enrollment to the end of follow-up at 2 weeks | bony decompression range; preservation rate of the facet joint |
| Creatine kinase (CK) | From enrollment to the end of follow-up at 2 weeks | — |
| Erythrocyte sedimentation rate (ESR) | From enrollment to the follow-up at 2 weeks | — |
| Surgical complication | From enrollment to the end of follow-up at 1 year | Adverse events will be recorded to assess the safety of decompression using UBE or UE for LSS. |
| VAS (visual analogue scale) for leg pain | From enrollment to the end of follow-up at 1 year | 0-10, the higher the score, the more severe the pain |
| VAS (visual analogue scale) for lower back pain | From enrollment to the end of follow-up at 1 year | 0-10, the higher the score, the more severe the pain |
| Japanese Orthopaedic Association (JOA) score | From enrollment to the end of follow-up at 1 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 1 year | According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor |
| Operation time | Immediately after the surgery | — |
| Blood loss | Immediately after the surgery | — |
| Postoperative hospital stays | Immediately after the discharge | — |
| Magnetic resonance imaging (MRI) | From enrollment to the follow-up at 2 weeks | Enlargement ratio of the dural sac |
| Gender | Baseline, pre-surgery | — |
| Body mass index (BMI) | Baseline, pre-surgery | — |
| Medical comorbidity | Baseline, pre-surgery | — |
| Smoking status | Baseline, pre-surgery | — |
| Alcohol status | Baseline, pre-surgery | — |
| Symptoms duration | Baseline, pre-surgery | — |
| Physical examination finding | Baseline, pre-surgery | — |
| Previous spinal surgery | Baseline, pre-surgery | — |
| Affected level | Baseline, pre-surgery | — |
| Stenosis grade | Baseline, pre-surgery | — |
| Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | From enrollment to the end of follow-up at 1 year | range, 0-100 points, with higher scores indicating better physical health-related quality of life |
| Age | Baseline, pre-surgery | — |
Countries
China
Outcome results
None listed