Clinical trial NCT06365229: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
Official title: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with LSS undergoing UBE or UE decompression performed by two experienced spine surgeons at the same hospital will be recruited for the study.

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).


Eligibility criteria: 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 \&amp;gt;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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: From enrollment to the end of follow-up at 1 year
Secondary outcomes:
measure: Magnetic resonance imaging (MRI)
timeFrame: From enrollment to the follow-up at 2 weeks
measure: Computed tomography (CT) scans
timeFrame: From enrollment to the end of follow-up at 2 weeks
measure: Creatine kinase (CK)
timeFrame: From enrollment to the end of follow-up at 2 weeks
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: From enrollment to the follow-up at 2 weeks
measure: Surgical complication
timeFrame: From enrollment to the end of follow-up at 1 year
measure: VAS (visual analogue scale) for leg pain
timeFrame: From enrollment to the end of follow-up at 1 year
measure: VAS (visual analogue scale) for lower back pain
timeFrame: From enrollment to the end of follow-up at 1 year
measure: Japanese Orthopaedic Association (JOA) score
timeFrame: From enrollment to the end of follow-up at 1 year
measure: Modified MacNab criteria
timeFrame: From enrollment to the end of follow-up at 1 year
measure: Operation time
timeFrame: Immediately after the surgery
measure: Blood loss
timeFrame: Immediately after the surgery
measure: Postoperative hospital stays
timeFrame: Immediately after the discharge
measure: Age
timeFrame: Baseline, pre-surgery
measure: Gender
timeFrame: Baseline, pre-surgery
measure: Body mass index (BMI)
timeFrame: Baseline, pre-surgery
measure: Medical comorbidity
timeFrame: Baseline, pre-surgery
measure: Smoking status
timeFrame: Baseline, pre-surgery
measure: Alcohol status
timeFrame: Baseline, pre-surgery
measure: Symptoms duration
timeFrame: Baseline, pre-surgery
measure: Physical examination finding
timeFrame: Baseline, pre-surgery
measure: Previous spinal surgery
timeFrame: Baseline, pre-surgery
measure: Affected level
timeFrame: Baseline, pre-surgery
measure: Stenosis grade
timeFrame: Baseline, pre-surgery
measure: Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: From enrollment to the end of follow-up at 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References: