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Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation

NCT02557113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-09-23

No results posted yet for this study

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

  • Vertebral Body Fracture

Interventions

PROCEDURE

Vertebroplasty

Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement

PROCEDURE

Cavuplasty

Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection

Sponsors & Collaborators

  • Mohammad ARAB MOTLAGH

    lead OTHER

Principal Investigators

  • Mohammad Arab Motlagh, MD · Department of Orthopaedic Surgery University Hospital Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-09-30
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02557113 on ClinicalTrials.gov