Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures (OSTEO-6)

December 13, 2014 updated by: Assistance Publique - Hôpitaux de Paris

Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks

This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.

Study Overview

Status

Status

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

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.

Detailed Description

The three treatments are the following: 1/Conventional medical treatment including rest and pain medications2/Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.3/Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement may be injected with low pressure into the created cavity. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than medical treatment and vertebroplasty.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure
  • Patient must have signed the consent form (ZELEN Randomization protocol)
  • Male or female, 50 years or older

  • One or two non-traumatic vertebral fracture(s):

    • Of osteoporotic origin (low speed trauma such as fall from his own height or less than 80 cm)
    • Fracture(s) of less than 6 weeks duration after the onset of pain related to the fracture The fracture(s) exhibit(s) high signal intensity on T2-weighted images and a benign appearance at MRI
  • The patient will be able to receive the selected protocol treatment within 6 weeks after onset of fracture-related symptoms and within 15 days after treatment randomization.
  • The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty or by one year follow-up in the conservative treatment group.

Exclusion Criteria:

  • Patient with a vertebral fracture of more than 6 week duration after onset of fracture-related symptoms.
  • Neurological signs related to the vertebral fracture to treat
  • History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
  • More than two recent vertebral fractures
  • Current infection
  • Impossibility to perform the percutaneous approach of the vertebra to treat.
  • Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat.
  • Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
  • Vertebral fracture with loss of 90%or more of the vertebral body height
  • Neurological signs or symptoms related to the vertebral fracture
  • Malignant and traumatic vertebral fractures

  • Contraindication to MRI :

    • Metallic implant : pace-maker, non movable auditive implant, metallic vascular or cardiac device
    • Metallic surgical clips
    • Claustrophobia
  • Evolutive cardiac disease nonreactive to medical treatment
  • Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
  • Presence of an unexplained biological inflammatory syndrome with NFS≥20
  • Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.
  • Pregnant or breast feeding women
  • Patient not affiliated to social security

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: None (Open Label)

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.
Other: 1
conventional treatment
Other: conventional treatment
with our without brace
Other Names:
  • antalgic drugs
Other: 2
kyphoplasty by balloons
Procedure: kyphoplasty with balloons
Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity.
Other: 3
vertebroplasty
Procedure: vertebroplasty
Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance

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
Time Frame
Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements.
Time Frame: 1 year
1 year

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
Time Frame
Intensity of signal with T2 sequence
Time Frame: preoperative and at J360
preoperative and at J360
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
1° - Pain evaluation using a visual analogic scale
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
questionnaire (Eifel) for back pain evaluation
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Quality of life evaluation (QUALEFFO - Short-Form SF12).
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Number of new vertebral fractures occurring during the one year follow-up period
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Cost evaluation in a sample of 10% of patients randomly selected including the following costs : o Intervention cost. o Medical treatment costs o Consultation costs. o Hospitalization cost o Complication costs
Time Frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts tomodensitometry (tdm) on the sagittal level : lateral right, median and lateral left
Time Frame: preoperative, at J6 and at J360
preoperative, at J6 and at J360

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.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

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: Jean-Denis LAREDO, MD,Pr, AP-HP Assistance Publique- Hôpitaux de Paris

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.
December 1, 2007

Primary Completion (Actual)

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.
June 1, 2012

Study Completion (Actual)

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.
June 1, 2012

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).
September 8, 2008

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.
September 8, 2008

First Posted (Estimate)

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.
September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

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.
December 16, 2014

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.
December 13, 2014

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.
December 1, 2014

More Information

Terms related to this study

Keywords

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.
  • P060107

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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