Clinical Trials Directory

Trials / Completed

CompletedNCT02557113

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Mohammad ARAB MOTLAGH · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREVertebroplastyFractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
PROCEDURECavuplastySmall Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection

Timeline

Start date
2011-01-01
Primary completion
2012-09-01
Completion
2013-01-01
First posted
2015-09-23
Last updated
2015-09-23

Source: ClinicalTrials.gov record NCT02557113. Inclusion in this directory is not an endorsement.

Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation (NCT02557113) · Clinical Trials Directory