Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

June 15, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The volume (cm^3) of injected ciment
Time Frame: Baseline (Day 0)
The volume of injected ciment is measured by catscan extrapolated data.
Baseline (Day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery of vertebral volume (%)
Time Frame: Day 1 to Day 7
Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.
Day 1 to Day 7
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 (°)
Days 1 to 7
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 (°)
1 month
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 (°)
3 months
Change from baseline in vertebral height (mm)
Time Frame: Days 1 to 7
Change in vertebra height (mm) before and after surgery
Days 1 to 7
Change from baseline in vertebral height (mm)
Time Frame: 1 month
Change in vertebra height (mm) before and after surgery
1 month
Change from baseline in vertebral height (mm)
Time Frame: 3 months
Change in vertebra height (mm) before and after surgery
3 months
Volume of ciment leakage (cm^3)
Time Frame: Day 1
The volume of ciment leakage will be determined according to catscan data.
Day 1
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
Day 0 (post-op)
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
1 month
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
3 months
% 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
Day 0 (post-op)
% 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
1 month
% 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
3 months
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
3 months
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
3 months
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
1 month
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
3 months
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
1 month
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
3 months
Change in FABQ score before and after surgery
Time Frame: 1 month
Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
1 month
Change in FABQ score before and after surgery
Time Frame: 3 months
Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
3 months
% 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
1 month
% 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
3 months
Change in DPQ score before and after surgery
Time Frame: 1 month
Change in the Dallas Pain Questionnaire score before and after surgery
1 month
Change in DPQ score before and after surgery
Time Frame: 3 months
Change in the Dallas Pain Questionnaire score before and after surgery
3 months
% Change in DPQ score before and after surgery
Time Frame: 3 months
Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
3 months
% Change in DPQ score before and after surgery
Time Frame: 1 month
Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
1 month
Duration of surgery (minutes)
Time Frame: Day 0 (day of surgery)
Length of operative time (minutes)
Day 0 (day of surgery)
Presence / absence of per-operative complications
Time Frame: Day 0 (day of surgery)
Presence / absence of per-operative complications
Day 0 (day of surgery)
Presence / absence of post-operative complications
Time Frame: 1 month
Presence / absence of post-operative complications
1 month
Presence / absence of post-operative complications
Time Frame: 3 months
Presence / absence of post-operative complications
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pascal Kouyoumdjian, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2011/PK-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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