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

NCT06394089 | Recruiting

• 1 other identifier: 2023-P2-293-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Degenerative Spondylolisthesis; 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 2 year

Secondary Outcomes (21)

• X-ray

  From enrollment to the end of follow-up at 2 year

• Computed tomography (CT) scan

  From enrollment to the end of follow-up at 2 year

• Magnetic resonance imaging (MRI)

  From enrollment to the end of follow-up at 2 year

• Surgical complication

  From enrollment to the end of follow-up at 2 year

• Visual analog scale (VAS) score for lower back pain

  From enrollment to the end of follow-up at 2 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients with LSS who are scheduled to undergo UBE-based decompression, performed by an experienced spine surgeon at Beijing Friendship Hospital, will be recruited from the outpatient clinic for this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41034885 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Xiang Li

CONTACT

+86 10 6313 9155; muzixiangxin2022@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: May 1, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)