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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394089
• Other study ID #: 2023-P2-293-01
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: April 2024
• Source: Beijing Friendship Hospital
• Contact: Xiang Li
• Phone: +86 10 6313 9155
• Email: muzixiangxin2022[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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 or 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 exceeding 15° 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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Spondylolisthesis
• Lumbar Spinal Stenosis
• Spinal Stenosis
• Spondylolisthesis

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From enrollment to the end of follow-up at 2 year
Secondary	Computed tomography (CT) scan	Assessment of bone resection area and preservation rate of the facet joint using postoperative computed tomography (CT) scans	From enrollment to the end of follow-up at 2 year
Secondary	Magnetic resonance imaging (MRI)	Calculation of the enlargement ratio of the dural sac based on postoperative magnetic resonance imaging (MRI)	From enrollment to the end of follow-up at 2 year
Secondary	Surgical complication	Any adverse events will be recorded to evaluate the safety of decompression using UBE for LSS with or without DS	From enrollment to the end of follow-up at 2 year
Secondary	Visual analog scale (VAS) score for lower back pain	0-10, the higher the score, the more severe the pain	From enrollment to the end of follow-up at 2 year
Secondary	Visual analog scale (VAS) score for leg pain	0-10, the higher the score, the more severe the pain	From enrollment to the end of follow-up at 2 year
Secondary	Creatine kinase (CK)		From enrollment to the end of follow-up at 2 year
Secondary	Erythrocyte sedimentation rate (ESR)		From enrollment to the end of follow-up at 2 year
Secondary	Operative time		Immediately after the surgery
Secondary	Intraoperative blood loss		Immediately after the surgery
Secondary	Postoperative hospital stays		Immediately after the discharge
Secondary	Japanese Orthopaedic Association (JOA) score	0-29, the higher the score, the better the lumbar spine function	From enrollment to the end of follow-up at 2 year
Secondary	Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey	0-100 points, with higher scores indicating better physical health-related quality of life	From enrollment to the end of follow-up at 2 year
Secondary	Modified MacNab criteria	According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor	From enrollment to the end of follow-up at 2 year
Secondary	Improvement ratio of Visual analog scale (VAS) score for lower back pain	Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms	From enrollment to the end of follow-up at 2 year
Secondary	Improvement ratio of Visual analog scale (VAS) score for leg pain	Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms	From enrollment to the end of follow-up at 2 year
Secondary	Improvement ratio of Japanese Orthopaedic Association (JOA) score	Improvement ratio= (postoperative JOA-preoperative JOA/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of spinal function	From enrollment to the end of follow-up at 2 year
Secondary	Improvement ratio of Oswestry Disability Index (ODI)	Improvement ratio= (preoperative ODI-postoperative ODI)/preoperative ODI, ranging from 0-100%, the higher the score, the better the improment of symptoms	From enrollment to the end of follow-up at 2 year