Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
- Conditions
- Registration Number
- NCT06365229
- Lead Sponsor
- Beijing Friendship Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
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 1 year 0-100%, the higher the score, the more severe the lumbar spine dysfunction
- Secondary Outcome Measures
Name Time Method Erythrocyte sedimentation rate (ESR) From enrollment to the follow-up at 2 weeks 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
Operation time Immediately after the surgery 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.
Blood loss Immediately after the surgery Gender Baseline, pre-surgery Computed tomography (CT) scans From enrollment to the end of follow-up at 2 weeks bony decompression range; preservation rate of the facet joint
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
Medical comorbidity Baseline, pre-surgery Previous spinal surgery Baseline, pre-surgery Creatine kinase (CK) From enrollment to the end of follow-up at 2 weeks 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
Postoperative hospital stays Immediately after the discharge Body mass index (BMI) Baseline, pre-surgery Smoking status Baseline, pre-surgery Alcohol status 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
Magnetic resonance imaging (MRI) From enrollment to the follow-up at 2 weeks Enlargement ratio of the dural sac
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
Age Baseline, pre-surgery Physical examination finding Baseline, pre-surgery Symptoms duration Baseline, pre-surgery Affected level Baseline, pre-surgery Stenosis grade Baseline, pre-surgery
Trial Locations
- Locations (1)
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China