Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

NCT ID: NCT06394089

Last Updated: 2025-06-06

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

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-02-28

Brief Summary

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A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis

Detailed Description

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Conditions

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Degenerative Spondylolisthesis Lumbar Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DS Group

Patients with degenerative spondylolisthesis Meyerding grade Ⅰ (slippage \>3 mm but \<25%) will be identified as having lumbar spinal stenosis combined with degenerative spondylolisthesis and will be allocated to the DS group.

No interventions assigned to this group

Non-DS Group

Patients not with degenerative spondylolisthesis will be identified as having lumbar spinal stenosis only and will be allocated to the Non-DS group.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age range: 50-80 years
* Diagnosis of LSS affecting 1-2 vertebral levels
* Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
* Presence of lumbar DS of less than grade II and absence of spine instability
* Willingness to participate in the study and complete follow-up assessments.

Exclusion Criteria

* Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
* Evidence of instability at the affected vertebral level (intervertebral angle change \> 15° and/or vertebral translation ≥ 4.5 mm in standing flexion-extension radiographs of the lumbar spine)
* History of prior surgery at the affected vertebral level
* Presence of scoliosis with a Cobb angle \>20º
* Presence of other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
* Medical disorders that preclude surgical tolerance
* Participation in other clinical research projects related to the treatment of lumbar spinal stenosis.
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 RECRUITING

Countries

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China

Central Contacts

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Xiang Li

Role: CONTACT

+86 10 6313 9155

Facility Contacts

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Yue Li

Role: primary

+86 10 6313 9006

References

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Liu Y, Li G, Yu L, Sun H, Zhu B, Fei Q, Lo Y, Yang Y, Tan H, Li X. Degenerative spondylolisthesis and unilateral biportal endoscopic decompression for lumbar spinal stenosis: a single-center, prospective cohort trial protocol. BMC Musculoskelet Disord. 2025 Oct 1;26(1):900. doi: 10.1186/s12891-025-09179-6.

Reference Type DERIVED
PMID: 41034885 (View on PubMed)

Other Identifiers

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2023-P2-293-01

Identifier Type: -

Identifier Source: org_study_id

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