Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

This study has been withdrawn prior to enrollment.
(Patients refuse randomization.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01402167
First received: July 25, 2011
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention
Vertebral Body Compression Fractures
Procedure: Kyphoplasty
Procedure: Vertebroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The volume (cm^3) of injected ciment [ Time Frame: Baseline (Day 0) ] [ Designated as safety issue: No ]
    The volume of injected ciment is measured by catscan extrapolated data.


Secondary Outcome Measures:
  • Recovery of vertebral volume (%) [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: No ]
    Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.

  • Change from baseline of the cyphotic angle (°) [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]
    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 (°) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 (°) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]
    Change in vertebra height (mm) before and after surgery

  • Change from baseline in vertebral height (mm) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change in vertebra height (mm) before and after surgery

  • Change from baseline in vertebral height (mm) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in vertebra height (mm) before and after surgery

  • Volume of ciment leakage (cm^3) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 (post-op) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 (post-op) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The change in the Oswestry Disability Index before and after surgery

  • The % change in the ODI score before and after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The percentage change (%) in the Oswestry Disability Index before and after surgery

  • Change in SF-36 quality of life score before and after surgery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change in SF-36 quality of life score before and after surgery

  • Change in SF-36 quality of life score before and after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Percentage change (%) in SF-36 quality of life score before and after surgery

  • Change in FABQ score before and after surgery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  • Change in FABQ score before and after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  • % Change in FABQ score before and after surgery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  • % Change in FABQ score before and after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

  • Change in DPQ score before and after surgery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change in the Dallas Pain Questionnaire score before and after surgery

  • Change in DPQ score before and after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in the Dallas Pain Questionnaire score before and after surgery

  • % Change in DPQ score before and after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

  • % Change in DPQ score before and after surgery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

  • Duration of surgery (minutes) [ Time Frame: Day 0 (day of surgery) ] [ Designated as safety issue: No ]
    Length of operative time (minutes)

  • Presence / absence of per-operative complications [ Time Frame: Day 0 (day of surgery) ] [ Designated as safety issue: Yes ]
    Presence / absence of per-operative complications

  • Presence / absence of post-operative complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Presence / absence of post-operative complications

  • Presence / absence of post-operative complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Presence / absence of post-operative complications


Enrollment: 0
Study Start Date: September 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402167

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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01402167     History of Changes
Other Study ID Numbers: LOCAL/2011/PK-04
Study First Received: July 25, 2011
Last Updated: August 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on September 16, 2014