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

Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial Protocol

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 Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
UBE Group; Patients with LSS undergoing UBE
UE Group; Patients with LSS undergoing UE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	0-100%, the higher the score, the more severe the lumbar spine dysfunction	From enrollment to the end of follow-up at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic resonance imaging (MRI)	Enlargement ratio of the dural sac	From enrollment to the follow-up at 2 weeks
Computed tomography (CT) scans	bony decompression range; preservation rate of the facet joint	From enrollment to the end of follow-up at 2 weeks
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	Adverse events will be recorded to assess the safety of decompression using UBE or UE for LSS.	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	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	From enrollment to the end of follow-up at 1 year
Japanese Orthopaedic Association (JOA) score	0-29, the higher the score, the better the lumbar spine function	From enrollment to the end of follow-up at 1 year
Modified MacNab criteria	According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor	From enrollment to the end of follow-up at 1 year
Operation time		Immediately after the surgery
Blood loss		Immediately after the surgery
Postoperative hospital stays		Immediately after the discharge
Age		Baseline, pre-surgery
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)	range, 0-100 points, with higher scores indicating better physical health-related quality of life	From enrollment to the end of follow-up at 1 year

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 2022-P2-336-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No