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Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

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: NCT01402167
Recruitment Status : Withdrawn (Patients refuse randomization.)
First Posted : July 26, 2011
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Vertebral Body Compression Fractures Procedure: Kyphoplasty Procedure: Vertebroplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry
Study Start Date : September 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Kyphoplasty
Patients randomized to this arm will be treated via balloon kyphoplasty.
Procedure: Kyphoplasty
Patients will be treated via a balloon kyphoplasty surgical procedure
Active Comparator: Vertebroplasty
Patients randomized to this arm will be treated via vertebroplasty.
Procedure: Vertebroplasty
Patients will be treated via a transcutaneous vertebroplasty procedure.


Outcome Measures

Primary Outcome Measures :
  1. The volume (cm^3) of injected ciment [ Time Frame: Baseline (Day 0) ]
    The volume of injected ciment is measured by catscan extrapolated data.


Secondary Outcome Measures :
  1. Recovery of vertebral volume (%) [ Time Frame: Day 1 to Day 7 ]
    Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.

  2. Change from baseline of the cyphotic angle (°) [ Time Frame: Days 1 to 7 ]
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)

  3. Change from baseline of the cyphotic angle (°) [ Time Frame: 1 month ]
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)

  4. Change from baseline of the cyphotic angle (°) [ Time Frame: 3 months ]
    The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)

  5. Change from baseline in vertebral height (mm) [ Time Frame: Days 1 to 7 ]
    Change in vertebra height (mm) before and after surgery

  6. Change from baseline in vertebral height (mm) [ Time Frame: 1 month ]
    Change in vertebra height (mm) before and after surgery

  7. Change from baseline in vertebral height (mm) [ Time Frame: 3 months ]
    Change in vertebra height (mm) before and after surgery

  8. Volume of ciment leakage (cm^3) [ Time Frame: Day 1 ]
    The volume of ciment leakage will be determined according to catscan data.

  9. Change in Visual Analog Scale (0 to 10) for pain before and after surgery [ Time Frame: Day 0 (post-op) ]
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery

  10. Change in Visual Analog Scale (0 to 10) for pain before and after surgery [ Time Frame: 1 month ]
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery

  11. Change in Visual Analog Scale (0 to 10) for pain before and after surgery [ Time Frame: 3 months ]
    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery

  12. % Change in Visual Analog Scale (0 to 10) for pain before and after surgery [ Time Frame: Day 0 (post-op) ]
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery

  13. % Change in Visual Analog Scale (0 to 10) for pain before and after surgery [ Time Frame: 1 month ]
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery

  14. % Change in Visual Analog Scale (0 to 10) for pain before and after surgery [ Time Frame: 3 months ]
    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery

  15. The change in the ODI score before and after surgery [ Time Frame: 3 months ]
    The change in the Oswestry Disability Index before and after surgery

  16. The % change in the ODI score before and after surgery [ Time Frame: 3 months ]
    The percentage change (%) in the Oswestry Disability Index before and after surgery

  17. Change in SF-36 quality of life score before and after surgery [ Time Frame: 1 month ]
    Change in SF-36 quality of life score before and after surgery

  18. Change in SF-36 quality of life score before and after surgery [ Time Frame: 3 months ]
    Change in SF-36 quality of life score before and after surgery

  19. The % change in SF-36 quality of life score before and after surgery [ Time Frame: 1 month ]
    Percentage change (%) in SF-36 quality of life score before and after surgery

  20. The % change in SF-36 quality of life score before and after surgery [ Time Frame: 3 months ]
    Percentage change (%) in SF-36 quality of life score before and after surgery

  21. Change in FABQ score before and after surgery [ Time Frame: 1 month ]
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  22. Change in FABQ score before and after surgery [ Time Frame: 3 months ]
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  23. % Change in FABQ score before and after surgery [ Time Frame: 1 month ]
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  24. % Change in FABQ score before and after surgery [ Time Frame: 3 months ]
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  25. Change in DPQ score before and after surgery [ Time Frame: 1 month ]
    Change in the Dallas Pain Questionnaire score before and after surgery

  26. Change in DPQ score before and after surgery [ Time Frame: 3 months ]
    Change in the Dallas Pain Questionnaire score before and after surgery

  27. % Change in DPQ score before and after surgery [ Time Frame: 3 months ]
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

  28. % Change in DPQ score before and after surgery [ Time Frame: 1 month ]
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

  29. Duration of surgery (minutes) [ Time Frame: Day 0 (day of surgery) ]
    Length of operative time (minutes)

  30. Presence / absence of per-operative complications [ Time Frame: Day 0 (day of surgery) ]
    Presence / absence of per-operative complications

  31. Presence / absence of post-operative complications [ Time Frame: 1 month ]
    Presence / absence of post-operative complications

  32. Presence / absence of post-operative complications [ Time Frame: 3 months ]
    Presence / absence of post-operative complications


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT01402167


Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pascal Kouyoumdjian, MD Centre Hospitalier Universitaire de Nîmes
More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01402167     History of Changes
Other Study ID Numbers: LOCAL/2011/PK-04
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Wounds and Injuries