Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 20, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedSeptember 23, 2015
September 1, 2015
1.7 years
September 20, 2015
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CT-Scan evaluation
Number of Cement Extravasation in each Vertebral Body
One week
Secondary Outcomes (1)
Visual Analogue Scale
3 Months
Study Arms (2)
Vertebroplasty
ACTIVE COMPARATORThis Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)
Cavuplasty
EXPERIMENTALThis Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)
Interventions
Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection
Eligibility Criteria
You may qualify if:
- Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification
You may not qualify if:
- More Than 2 Vertebral Body Fractures
- Fractures of Vertebral Body Based on Malignancy
- Previous Spinal Operation
- Spinal Infection
- Spinal Deformity (scoliosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammad Arab Motlagh, MD
Department of Orthopaedic Surgery University Hospital Frankfurt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
September 20, 2015
First Posted
September 23, 2015
Study Start
January 1, 2011
Primary Completion
September 1, 2012
Study Completion
January 1, 2013
Last Updated
September 23, 2015
Record last verified: 2015-09