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Withdrawn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
About this trial
This is an interventional treatment trial for Vertebral Body Compression Fractures
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
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
NCT ID
NCT01402167
First Posted
July 25, 2011
Last Updated
March 24, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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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