Status:
UNKNOWN
Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Park MC
Maasstad Hospital
Conditions:
Stenoses, Spinal
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not availa...
Detailed Description
Intermittent neurogenic claudication (INC) caused by a lumbar spinal canal stenosis (LSS) is the most frequent reason for spinal surgery in the elderly. Multiple, less invasive surgical techniques are...
Eligibility Criteria
Inclusion
- At least 12 weeks of complaints of INC
- Magnetic resonance imaging showing LSS
- Age \>40 years of age
- Sufficient knowledge of the Dutch language
- Signed informed consent
Exclusion
- History of lumbar spine surgery
- \>2 lumbar levels operation or needed discectomy
- Degenerative spondylolisthesis \> grade 1 (on a scale of 1 to 4), scoliosis or disc herniation
- ASA-classification \>3
- Serious psychopathology
- Pregnancy
- Active malignancy
- Plans to move abroad during study period
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03480893
Start Date
March 1 2020
End Date
April 1 2024
Last Update
July 27 2022
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE