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Vertebral Body Compression FracturesNCT01402167

Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

A study testing Kyphoplasty and Vertebroplasty in people with Vertebral Body Compression Fractures, run by Centre Hospitalier Universitaire de Nīmes.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Vertebral Body Compression Fractures
What is being tested?
Kyphoplasty and Vertebroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2014to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

Official title: Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry

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.

Being tested
Kyphoplasty, Vertebroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KyphoplastyProcedure or surgery

    Patients will be treated via a balloon kyphoplasty surgical procedure

  • VertebroplastyProcedure or surgery

    Patients will be treated via a transcutaneous vertebroplasty procedure.

Study groups in NCT01402167
Study groupRoleWhat they receive
KyphoplastyExperimentalPatients randomized to this arm will be treated via balloon kyphoplasty.
Receives: Procedure: Kyphoplasty
VertebroplastyActive comparatorPatients randomized to this arm will be treated via vertebroplasty.
Receives: Procedure: Vertebroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The volume (cm^3) of injected ciment

    The volume of injected ciment is measured by catscan extrapolated data.

    Measured: Baseline (Day 0)

Secondary outcomes (32)

  1. Recovery of vertebral volume (%)

    Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.

    Measured: Day 1 to Day 7

  2. 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 (°)

    Measured: Days 1 to 7

  3. 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 (°)

    Measured: 1 month

  4. 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 (°)

    Measured: 3 months

  5. Change from baseline in vertebral height (mm)

    Change in vertebra height (mm) before and after surgery

    Measured: Days 1 to 7

  6. Change from baseline in vertebral height (mm)

    Change in vertebra height (mm) before and after surgery

    Measured: 1 month

  7. Change from baseline in vertebral height (mm)

    Change in vertebra height (mm) before and after surgery

    Measured: 3 months

  8. Volume of ciment leakage (cm^3)

    The volume of ciment leakage will be determined according to catscan data.

    Measured: Day 1

  9. 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

    Measured: Day 0 (post-op)

  10. 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

    Measured: 1 month

  11. 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

    Measured: 3 months

  12. % 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

    Measured: Day 0 (post-op)

  13. % 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

    Measured: 1 month

  14. % 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

    Measured: 3 months

  15. The change in the ODI score before and after surgery

    The change in the Oswestry Disability Index before and after surgery

    Measured: 3 months

  16. The % change in the ODI score before and after surgery

    The percentage change (%) in the Oswestry Disability Index before and after surgery

    Measured: 3 months

  17. Change in SF-36 quality of life score before and after surgery

    Change in SF-36 quality of life score before and after surgery

    Measured: 1 month

  18. Change in SF-36 quality of life score before and after surgery

    Change in SF-36 quality of life score before and after surgery

    Measured: 3 months

  19. 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

    Measured: 1 month

  20. 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

    Measured: 3 months

  21. Change in FABQ score before and after surgery

    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

    Measured: 1 month

  22. Change in FABQ score before and after surgery

    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

    Measured: 3 months

  23. % Change in FABQ score before and after surgery

    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

    Measured: 1 month

  24. % Change in FABQ score before and after surgery

    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

    Measured: 3 months

  25. Change in DPQ score before and after surgery

    Change in the Dallas Pain Questionnaire score before and after surgery

    Measured: 1 month

  26. Change in DPQ score before and after surgery

    Change in the Dallas Pain Questionnaire score before and after surgery

    Measured: 3 months

  27. % Change in DPQ score before and after surgery

    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

    Measured: 3 months

  28. % Change in DPQ score before and after surgery

    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

    Measured: 1 month

  29. Duration of surgery (minutes)

    Length of operative time (minutes)

    Measured: Day 0 (day of surgery)

  30. Presence / absence of per-operative complications

    Presence / absence of per-operative complications

    Measured: Day 0 (day of surgery)

  31. Presence / absence of post-operative complications

    Presence / absence of post-operative complications

    Measured: 1 month

  32. Presence / absence of post-operative complications

    Presence / absence of post-operative complications

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2011 (estimated)
  2. Study startSep 2014
  3. Primary completionMay 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Why it stopped: Patients refuse randomization.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01402167
Sponsor's protocol ID
LOCAL/2011/PK-04
Status last verified
Mar 2015
First submitted
25 Jul 2011
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Kyphoplasty and Vertebroplasty in people with Vertebral Body Compression Fractures, run by Centre Hospitalier Universitaire de Nīmes.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The volume (cm^3) of injected ciment (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01402167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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