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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorBeijing Friendship Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: DS Group
Group B: Non-DS Group

Trial outcomes

Primary outcomes

1

Oswestry Disability Index (ODI)

0-100%, the higher the score, the more severe the lumbar spine dysfunction

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

Secondary outcomes

1

X-ray

Progression of lumbar spondylolisthesis, assessed by postoperative lumbar radiography; (2) Measurement of sagittal translation, segmental angulation, and posterior opening based on postoperative standing flexion-extension radiographs

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

Computed tomography (CT) scan

Assessment of bone resection area and preservation rate of the facet joint using postoperative computed tomography (CT) scans

Time frame
From enrollment to the end of follow-up at 2 year
3

Magnetic resonance imaging (MRI)

Calculation of the enlargement ratio of the dural sac based on postoperative magnetic resonance imaging (MRI)

Time frame
From enrollment to the end of follow-up at 2 year
4

Surgical complication

Any adverse events will be recorded to evaluate the safety of decompression using UBE for LSS with or without DS

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

Other outcomes

Sponsors and contacts

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