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

Primary Purpose

Vertebral Body Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vertebroplasty
Cavuplasty
Sponsored by
Mohammad ARAB MOTLAGH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Body Fracture focused on measuring cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Vertebroplasty

    Cavuplasty

    Arm Description

    This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)

    This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)

    Outcomes

    Primary Outcome Measures

    CT-Scan evaluation
    Number of Cement Extravasation in each Vertebral Body

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 20, 2015
    Last Updated
    September 21, 2015
    Sponsor
    Mohammad ARAB MOTLAGH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02557113
    Brief Title
    Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohammad ARAB MOTLAGH

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vertebral Body Fracture
    Keywords
    cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vertebroplasty
    Arm Type
    Active Comparator
    Arm Description
    This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)
    Arm Title
    Cavuplasty
    Arm Type
    Experimental
    Arm Description
    This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)
    Intervention Type
    Procedure
    Intervention Name(s)
    Vertebroplasty
    Intervention Description
    Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
    Intervention Type
    Procedure
    Intervention Name(s)
    Cavuplasty
    Intervention Description
    Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection
    Primary Outcome Measure Information:
    Title
    CT-Scan evaluation
    Description
    Number of Cement Extravasation in each Vertebral Body
    Time Frame
    One week
    Secondary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    Scores range from 0 (no pain) to 10 (worst possible pain)
    Time Frame
    3 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Arab Motlagh, MD
    Organizational Affiliation
    Department of Orthopaedic Surgery University Hospital Frankfurt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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