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

NCT06365229 | Completed

• 1 other identifier: 2022-P2-336-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Magnetic resonance imaging (MRI)

  From enrollment to the follow-up at 2 weeks

• Computed tomography (CT) scans

  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

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

Study Arms (2)

UBE Group

Patients with LSS undergoing UBE

UE Group

Patients with LSS undergoing UE

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• Tan H, Liu Y, Li G, Yu L, Yang Y, Lo Y, Bin Z, Li X. Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol. BMJ Open. 2025 Jul 25;15(7):e087863. doi: 10.1136/bmjopen-2024-087863.

  PMID: 40713043 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 15, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)