Clinical trial NCT06394089: Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
Official title: Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Spondylolisthesis
Lumbar Spinal Stenosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: From enrollment to the end of follow-up at 2 year
Secondary outcomes:
measure: X-ray
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Computed tomography (CT) scan
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Magnetic resonance imaging (MRI)
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Surgical complication
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Visual analog scale (VAS) score for lower back pain
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Visual analog scale (VAS) score for leg pain
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Operative time
timeFrame: Immediately after the surgery
measure: Intraoperative blood loss
timeFrame: Immediately after the surgery
measure: Postoperative hospital stays
timeFrame: Immediately after the discharge
measure: Japanese Orthopaedic Association (JOA) score
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Modified MacNab criteria
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Improvement ratio of Visual analog scale (VAS) score for lower back pain
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Improvement ratio of Visual analog scale (VAS) score for leg pain
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Improvement ratio of Japanese Orthopaedic Association (JOA) score
timeFrame: From enrollment to the end of follow-up at 2 year
measure: Improvement ratio of Oswestry Disability Index (ODI)
timeFrame: From enrollment to the end of follow-up at 2 year
measure: White blood cell count
timeFrame: From enrollment to 3 days after surgery
measure: Percentage of neutrophils (N%)
timeFrame: From enrollment to 3 days after surgery
measure: C-reactive protein level
timeFrame: From enrollment to 3 days after surgery
measure: Creatine kinase level
timeFrame: From enrollment to 3 days after surgery
measure: Lactate dehydrogenase level
timeFrame: From enrollment to 3 days after surgery
measure: Myoglobin level
timeFrame: From enrollment to 3 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References: