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Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Primary Purpose

Vertebral Body Compression Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kyphoplasty
Vertebroplasty
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Body Compression Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 3 months of follow-up
  • Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
  • Cyphose of >10°
  • Spinal pain
  • Vertebral fracture < 3 weeks old located between D5 and L5
  • If fragments in the canal, they must protrude less than 40%
  • Absence of other lesions, including cancer

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Patient cannot read French
  • Patient is pregnant or breast feeding
  • Patient has a fracture on an adjacent vertebra
  • Patient has a contra-indication for a treatment used in this study
  • ASA class IV or V
  • Patient has a neurological deficit
  • Previous spinal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Kyphoplasty

    Vertebroplasty

    Arm Description

    Patients randomized to this arm will be treated via balloon kyphoplasty.

    Patients randomized to this arm will be treated via vertebroplasty.

    Outcomes

    Primary Outcome Measures

    The volume (cm^3) of injected ciment
    The volume of injected ciment is measured by catscan extrapolated data.

    Secondary Outcome Measures

    Recovery of vertebral volume (%)
    Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.
    Change from baseline of the cyphotic angle (°)
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
    Change from baseline of the cyphotic angle (°)
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
    Change from baseline of the cyphotic angle (°)
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
    Change from baseline in vertebral height (mm)
    Change in vertebra height (mm) before and after surgery
    Change from baseline in vertebral height (mm)
    Change in vertebra height (mm) before and after surgery
    Change from baseline in vertebral height (mm)
    Change in vertebra height (mm) before and after surgery
    Volume of ciment leakage (cm^3)
    The volume of ciment leakage will be determined according to catscan data.
    Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
    % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
    % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
    % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
    The change in the ODI score before and after surgery
    The change in the Oswestry Disability Index before and after surgery
    The % change in the ODI score before and after surgery
    The percentage change (%) in the Oswestry Disability Index before and after surgery
    Change in SF-36 quality of life score before and after surgery
    Change in SF-36 quality of life score before and after surgery
    Change in SF-36 quality of life score before and after surgery
    Change in SF-36 quality of life score before and after surgery
    The % change in SF-36 quality of life score before and after surgery
    Percentage change (%) in SF-36 quality of life score before and after surgery
    The % change in SF-36 quality of life score before and after surgery
    Percentage change (%) in SF-36 quality of life score before and after surgery
    Change in FABQ score before and after surgery
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    Change in FABQ score before and after surgery
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    % Change in FABQ score before and after surgery
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    % Change in FABQ score before and after surgery
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    Change in DPQ score before and after surgery
    Change in the Dallas Pain Questionnaire score before and after surgery
    Change in DPQ score before and after surgery
    Change in the Dallas Pain Questionnaire score before and after surgery
    % Change in DPQ score before and after surgery
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
    % Change in DPQ score before and after surgery
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
    Duration of surgery (minutes)
    Length of operative time (minutes)
    Presence / absence of per-operative complications
    Presence / absence of per-operative complications
    Presence / absence of post-operative complications
    Presence / absence of post-operative complications
    Presence / absence of post-operative complications
    Presence / absence of post-operative complications

    Full Information

    First Posted
    July 25, 2011
    Last Updated
    March 24, 2015
    Sponsor
    Centre Hospitalier Universitaire de Nīmes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01402167
    Brief Title
    Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures
    Official Title
    Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Patients refuse randomization.
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    August 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nīmes

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vertebral Body Compression Fractures

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Kyphoplasty
    Arm Type
    Experimental
    Arm Description
    Patients randomized to this arm will be treated via balloon kyphoplasty.
    Arm Title
    Vertebroplasty
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to this arm will be treated via vertebroplasty.
    Intervention Type
    Procedure
    Intervention Name(s)
    Kyphoplasty
    Intervention Description
    Patients will be treated via a balloon kyphoplasty surgical procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Vertebroplasty
    Intervention Description
    Patients will be treated via a transcutaneous vertebroplasty procedure.
    Primary Outcome Measure Information:
    Title
    The volume (cm^3) of injected ciment
    Description
    The volume of injected ciment is measured by catscan extrapolated data.
    Time Frame
    Baseline (Day 0)
    Secondary Outcome Measure Information:
    Title
    Recovery of vertebral volume (%)
    Description
    Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.
    Time Frame
    Day 1 to Day 7
    Title
    Change from baseline of the cyphotic angle (°)
    Description
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
    Time Frame
    Days 1 to 7
    Title
    Change from baseline of the cyphotic angle (°)
    Description
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
    Time Frame
    1 month
    Title
    Change from baseline of the cyphotic angle (°)
    Description
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
    Time Frame
    3 months
    Title
    Change from baseline in vertebral height (mm)
    Description
    Change in vertebra height (mm) before and after surgery
    Time Frame
    Days 1 to 7
    Title
    Change from baseline in vertebral height (mm)
    Description
    Change in vertebra height (mm) before and after surgery
    Time Frame
    1 month
    Title
    Change from baseline in vertebral height (mm)
    Description
    Change in vertebra height (mm) before and after surgery
    Time Frame
    3 months
    Title
    Volume of ciment leakage (cm^3)
    Description
    The volume of ciment leakage will be determined according to catscan data.
    Time Frame
    Day 1
    Title
    Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Description
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Time Frame
    Day 0 (post-op)
    Title
    Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Description
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Time Frame
    1 month
    Title
    Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Description
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Time Frame
    3 months
    Title
    % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Description
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
    Time Frame
    Day 0 (post-op)
    Title
    % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Description
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
    Time Frame
    1 month
    Title
    % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
    Description
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
    Time Frame
    3 months
    Title
    The change in the ODI score before and after surgery
    Description
    The change in the Oswestry Disability Index before and after surgery
    Time Frame
    3 months
    Title
    The % change in the ODI score before and after surgery
    Description
    The percentage change (%) in the Oswestry Disability Index before and after surgery
    Time Frame
    3 months
    Title
    Change in SF-36 quality of life score before and after surgery
    Description
    Change in SF-36 quality of life score before and after surgery
    Time Frame
    1 month
    Title
    Change in SF-36 quality of life score before and after surgery
    Description
    Change in SF-36 quality of life score before and after surgery
    Time Frame
    3 months
    Title
    The % change in SF-36 quality of life score before and after surgery
    Description
    Percentage change (%) in SF-36 quality of life score before and after surgery
    Time Frame
    1 month
    Title
    The % change in SF-36 quality of life score before and after surgery
    Description
    Percentage change (%) in SF-36 quality of life score before and after surgery
    Time Frame
    3 months
    Title
    Change in FABQ score before and after surgery
    Description
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    Time Frame
    1 month
    Title
    Change in FABQ score before and after surgery
    Description
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    Time Frame
    3 months
    Title
    % Change in FABQ score before and after surgery
    Description
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    Time Frame
    1 month
    Title
    % Change in FABQ score before and after surgery
    Description
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
    Time Frame
    3 months
    Title
    Change in DPQ score before and after surgery
    Description
    Change in the Dallas Pain Questionnaire score before and after surgery
    Time Frame
    1 month
    Title
    Change in DPQ score before and after surgery
    Description
    Change in the Dallas Pain Questionnaire score before and after surgery
    Time Frame
    3 months
    Title
    % Change in DPQ score before and after surgery
    Description
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
    Time Frame
    3 months
    Title
    % Change in DPQ score before and after surgery
    Description
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
    Time Frame
    1 month
    Title
    Duration of surgery (minutes)
    Description
    Length of operative time (minutes)
    Time Frame
    Day 0 (day of surgery)
    Title
    Presence / absence of per-operative complications
    Description
    Presence / absence of per-operative complications
    Time Frame
    Day 0 (day of surgery)
    Title
    Presence / absence of post-operative complications
    Description
    Presence / absence of post-operative complications
    Time Frame
    1 month
    Title
    Presence / absence of post-operative complications
    Description
    Presence / absence of post-operative complications
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 3 months of follow-up Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2 Cyphose of >10° Spinal pain Vertebral fracture < 3 weeks old located between D5 and L5 If fragments in the canal, they must protrude less than 40% Absence of other lesions, including cancer Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient Patient cannot read French Patient is pregnant or breast feeding Patient has a fracture on an adjacent vertebra Patient has a contra-indication for a treatment used in this study ASA class IV or V Patient has a neurological deficit Previous spinal surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pascal Kouyoumdjian, MD
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nîmes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

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