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OpenTrials
Completed

NCT Number: NCT02557113

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

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.

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Key information

Conditions

Vertebral Body Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vertebroplasty

Procedure

Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement

Cavuplasty

Procedure

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

Primary outcomes

  1. CT-Scan evaluation

    Time frame: One week

    Number of Cement Extravasation in each Vertebral Body

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: 3 Months

    Scores range from 0 (no pain) to 10 (worst possible pain)

Sponsors and collaborators

Lead sponsor

Mohammad ARAB MOTLAGH

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 23, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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