Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

Beijing Friendship Hospital120 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Lumbar Spinal Stenosis

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 \&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

Locations (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

0-100%, the higher the score, the more severe the lumbar spine dysfunction

Time frame: From enrollment to the end of follow-up at 1 year

Secondary Outcomes

Magnetic resonance imaging (MRI)

Enlargement ratio of the dural sac

Time frame: From enrollment to the follow-up at 2 weeks

Computed tomography (CT) scans

bony decompression range; preservation rate of the facet joint

Time frame: From enrollment to the end of follow-up at 2 weeks

Creatine kinase (CK)

Time frame: From enrollment to the end of follow-up at 2 weeks

Erythrocyte sedimentation rate (ESR)

Time frame: From enrollment to the follow-up at 2 weeks

Surgical complication

Adverse events will be recorded to assess the safety of decompression using UBE or UE for LSS.

Time frame: From enrollment to the end of follow-up at 1 year

VAS (visual analogue scale) for leg pain

0-10, the higher the score, the more severe the pain

Time frame: From enrollment to the end of follow-up at 1 year

VAS (visual analogue scale) for lower back pain

0-10, the higher the score, the more severe the pain

Time frame: From enrollment to the end of follow-up at 1 year

Data from ClinicalTrials.gov

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