Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

Lumbar Spinal Stenosis Clinical Trial

Official title:

Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06365229
• Other study ID #: 2022-P2-336-02
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age range: 50-80 years

• Diagnosed with LSS of 1-2 response levels

• The predominant manifestation is neurogenic intermittent claudication, and conservative treatment has been ineffective for at least 3 months

• Degenerative lumbar spondylolisthesis of less than I degree or without spine instability

• Patients agree to participate in the study and are willing to complete the follow-up

Exclusion Criteria:

• Isthmic lumbar spondylolisthesis or degenerative lumbar spondylolisthesis of greater than I degree

• Instability at the response level

• Prior surgical history at the response level

• Scoliosis with Cobb angle >20 degrees

• Other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)

• Patients with medical disorders who are unable to tolerate surgery

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

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 1 year
Secondary	Magnetic resonance imaging (MRI)	Enlargement ratio of the dural sac	From enrollment to the follow-up at 2 weeks
Secondary	Computed tomography (CT) scans	bony decompression range; preservation rate of the facet joint	From enrollment to the end of follow-up at 2 weeks
Secondary	Creatine kinase (CK)		From enrollment to the end of follow-up at 2 weeks
Secondary	Erythrocyte sedimentation rate (ESR)		From enrollment to the follow-up at 2 weeks
Secondary	Surgical complication	Adverse events will be recorded to assess the safety of decompression using UBE or UE for LSS.	From enrollment to the end of follow-up at 1 year
Secondary	VAS (visual analogue scale) for leg pain	0-10, the higher the score, the more severe the pain	From enrollment to the end of follow-up at 1 year
Secondary	VAS (visual analogue scale) for lower back pain	0-10, the higher the score, the more severe the pain	From enrollment to the end of follow-up at 1 year
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 1 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 1 year
Secondary	Operation time		Immediately after the surgery
Secondary	Blood loss		Immediately after the surgery
Secondary	Postoperative hospital stays		Immediately after the discharge
Secondary	Age		Baseline, pre-surgery
Secondary	Gender		Baseline, pre-surgery
Secondary	Body mass index (BMI)		Baseline, pre-surgery
Secondary	Medical comorbidity		Baseline, pre-surgery
Secondary	Smoking status		Baseline, pre-surgery
Secondary	Alcohol status		Baseline, pre-surgery
Secondary	Symptoms duration		Baseline, pre-surgery
Secondary	Physical examination finding		Baseline, pre-surgery
Secondary	Previous spinal surgery		Baseline, pre-surgery
Secondary	Affected level		Baseline, pre-surgery
Secondary	Stenosis grade		Baseline, pre-surgery
Secondary	Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)	range, 0-100 points, with higher scores indicating better physical health-related quality of life	From enrollment to the end of follow-up at 1 year