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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Ministry of Health, France |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00749060 |
This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.
Condition | Intervention |
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Osteoporotic Vertebral Fracture Between T5 and L5 of Less Than 6 Weeks Duration |
Other: conventional treatment Procedure: kyphoplasty with balloons Procedure: vertebroplasty |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks |
Estimated Enrollment: | 300 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
conventional treatment
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Other: conventional treatment
with our without brace
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2
kyphoplasty by balloons
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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.
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3
vertebroplasty
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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
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One or two non-traumatic vertebral fracture(s):
Exclusion Criteria:
Contraindication to MRI :
Contact: LAREDO Jean-Denis, M.D.Pr. | +331 49 95 9106 | jean-denis.laredo@lrb.aphp.fr |
France | |
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire | Recruiting |
Paris, France, 75010 | |
Contact: Laredo Jean-Denis, MD,Pr +331 4995 9106 jean-denis.laredo@lrb.aphp.fr/jean-denis.laredo@uphs.upenn.edu | |
Sub-Investigator: Hamze Bassam, MD | |
Principal Investigator: Laredo Jean-Denis, M.D.,PR. | |
Sub-Investigator: Bossard Philippe, MD | |
Sub-Investigator: Vergnol Jean-François, MD |
Principal Investigator: | LAREDO Jean-Denis, MD,Pr | AP-HP Assistance Publique- Hôpitaux de Paris |
Responsible Party: | Department of clinical research and development ( Cécile JOURDAIN ) |
Study ID Numbers: | P060107, 2006-A00467-44 |
Study First Received: | September 8, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00749060 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
osteoporosis non-traumatic vertebral fracture vertebral compression Balloon kyphoplasty vertebroplasty |
Polymethyl Methacrylate Spinal Injuries Fractures, Bone Back Injuries |
Wounds and Injuries Spinal Fractures Disorders of Environmental Origin Osteoporosis |