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

September 21, 2015 updated by: Mohammad ARAB MOTLAGH

Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vertebroplasty
This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)
Procedure: Vertebroplasty
Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
Experimental: Cavuplasty
This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)
Procedure: Cavuplasty
Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT-Scan evaluation
Time Frame: One week
Number of Cement Extravasation in each Vertebral Body
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 3 Months
Scores range from 0 (no pain) to 10 (worst possible pain)
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammad ARAB MOTLAGH

Investigators

  • Study Director: Mohammad Arab Motlagh, MD, Department of Orthopaedic Surgery University Hospital Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 20, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cavuplasty

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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