Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures
NCT ID: NCT00749060
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2007-12-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
conventional treatment
conventional treatment
with our without brace
2
kyphoplasty by balloons
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.
3
vertebroplasty
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
Interventions
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conventional treatment
with our without brace
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Denis LAREDO, MD,Pr
Role: PRINCIPAL_INVESTIGATOR
AP-HP Assistance Publique- Hôpitaux de Paris
Locations
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Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, , France
Countries
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Other Identifiers
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P060107
Identifier Type: -
Identifier Source: org_study_id