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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06365229
Other study ID # 2022-P2-336-02
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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