NCT02557113CompletedNot Applicable
Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
Mohammad ARAB MOTLAGH0 sites36 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Primary Endpoint
- CT-Scan evaluation
Study Overview
Brief Summary
Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification
Exclusion Criteria
- •More Than 2 Vertebral Body Fractures
- •Fractures of Vertebral Body Based on Malignancy
- •Previous Spinal Operation
- •Spinal Infection
- •Spinal Deformity (scoliosis)
Outcomes
Primary Outcomes
CT-Scan evaluation
Time Frame: One week
Number of Cement Extravasation in each Vertebral Body
Secondary Outcomes
- Visual Analogue Scale(3 Months)
Investigators
Mohammad ARAB MOTLAGH
Dr. med.
Johann Wolfgang Goethe University Hospital
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