Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557113
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment Phase
Vertebral Body Fracture Procedure: Vertebroplasty Procedure: Cavuplasty Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
Study Start Date : January 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. CT-Scan evaluation [ Time Frame: One week ]
    Number of Cement Extravasation in each Vertebral Body


Secondary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 3 Months ]
    Scores range from 0 (no pain) to 10 (worst possible pain)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557113


Sponsors and Collaborators
Mohammad ARAB MOTLAGH
Investigators
Layout table for investigator information
Study Director: Mohammad Arab Motlagh, MD Department of Orthopaedic Surgery University Hospital Frankfurt
Layout table for additonal information
Responsible Party: Mohammad ARAB MOTLAGH, Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02557113    
Other Study ID Numbers: Cavuplasty
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital:
cement leakage
cement augmentation
vertebral body fracture
vertebral cavity
vertebroplasty
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries