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

NCT ID: NCT06365229

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Lumbar Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UBE Group

Patients with LSS undergoing UBE

No interventions assigned to this group

UE Group

Patients with LSS undergoing UE

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40713043 (View on PubMed)

Other Identifiers

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2022-P2-336-02

Identifier Type: -

Identifier Source: org_study_id

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