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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: | NCT00749086 |
This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following:
Condition | Intervention | Phase |
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Osteoporotic Vertebral Fracture Between T5 and L5 Older Than 6 Weeks |
Device: balloon kyphoplasty Procedure: vertebroplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Study of Balloon Kyphoplasty and Vertebroplasty in Subacute (Older Than 6 Weeks) Osteoporotic Vertebral Fractures (STIC2) |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
balloon kyphoplasty
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Device: balloon kyphoplasty
Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is first placed into the fractured vertebra and inflated with fluid in order to create a cavity. Then, the balloon are deflated and removed. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure.
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1: Active Comparator
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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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: Jean-Denis LAREDO, M.D., PR. | +331 4995 9106 | jean-denis.laredo@lrb.aphp.fr |
France | |
Service de Radiologie, Hôpital Lariboisière | Recruiting |
Paris, France, 75010 | |
Contact: Jean-Denis LAREDO, M.D.,PR. +331 4995 9106 jean-denis.laredo@lrb.aphp.fr | |
Sub-Investigator: Bassam HAMZE, M.D. | |
Sub-Investigator: Jean-François VERGNOL, M.D. | |
Sub-Investigator: Philippe BOSSARD, MD |
Principal Investigator: | Jean-Denis LAREDO, M.D.,PR. | AP-HP Assistance Publique- Hôpitaux de Paris |
Responsible Party: | Department of clinical research and development ( Cécile JOURDAIN ) |
Study ID Numbers: | P060108, 2006-A00478-43 |
Study First Received: | September 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00749086 History of Changes |
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 |
Spinal Injuries Fractures, Bone Back Injuries |
Wounds and Injuries Spinal Fractures Disorders of Environmental Origin |