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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: | NCT00749242 |
This study will compare two treatments in acute stable traumatic vertebral fractures (types A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings:
Condition | Intervention | Phase |
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An Unique Vertebral Fracture |
Other: orthopedic corset Device: balloon kyphoplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Study Comparing Balloon Kyphoplasty and Conservative Treatment in Acute Traumatic Vertebral Fractures, Types A1, A2, AND A3.1 According to the MAGERL Classification (STIC 3) |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
conventional orthopedic brace
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Other: orthopedic corset
antalgic drugs and orthopedic brace
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2
balloon kyphoplasty
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Device: balloon kyphoplasty
introduction of balloon into the vertebral body, inflation of the balloon which creates a cavity, then balloon is deflated and removed , then introduction of the cement into the cavity.
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There is no reported frequency of stable thoracic or lumbar fractures traumatic fractures. However, the number of cases has been evaluated to be 61,425 yearly in Europe. Types A1 and A3.1 represent 61% of this number i.e. 37,468 per year in Europe and 4,600 in France.Conventional Conservative treatment of these fractures consists of brace and pain medication. However, a growing number of surgical teams use vertebroplasty or Balloon Kyphoplasty to avoid secondary fracture displacement after brace removal which results in increased kyphosis. However no study has compared the benefit of these new techniques to conservative managementThe goal of this study is to indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than Conservative Treatment.
1. The conventional orthopedic treatment is based on The Böhler Brace which extends from the manubrium to the pubic symphysis allowing spinal immobilisation in position of lumbar lordosis. Patients wear it for 3 to 6 months. It is a non-invasive treatment. However, kyphotic spine angle may increase over time despite the brace due to spine loading . 2 . Balloon Kyphoplasty is a variant of vertebroplasty which is performed under general anaesthesia using the KyphX® System (Medtronic., Sunnyvale, California). Balloon kyphoplasty aims at restore vertebral height of the fractured vertebra using an inflatable balloon prior to inject surgical cement (PMMA) into the vertebral body to fix the fracture. It is an expensive technique costing around 4,000 euros for up to 2 vertebrae in the same patient.
The surgical technique for the procedure has been described by Lieberman et al: A bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach. Fluoroscopy is used to insert the tools and control the procedure. With reaming tools, two working channels are created and the balloons are inserted. The balloons are available in lengths of 10, 15 and 20 mm.The two balloons(one on each side) should ideally be centered at middle height between the superior and inferior endplates and in the anterior two-thirds of the vertebral body. Balloon placement into the vertebral body is checked using radiopaque markers at the two extremities of the balloon. Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity. Inflation is stopped when one of the following inflation endpoints is reached: pressure raised over 400 psi, balloon contacts one of the cortical bone of the vertebra or reaching maximal balloon inflation volume. The balloons are then deflated and removed. The mean balloon inflation volume is 2 to 3ml. The Bone Filler Device, filled before with 1.5 ml of polymethylmethacrylate (PMMA), is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula. This step is repeated till a complete fill of the cavity is obtained. The same procedure is repeated through the other working cannula at the contra-lateral pedicle. Filling of the cavity with highly viscous PMMA is performed under continuous fluoroscopic control.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindication to MRI :
Contact: Jean-Denis LAREDO, MD,Pr | +331 4995 91 06 | jean-denis.laredo@lrb.aphp.fr |
France | |
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire | Recruiting |
PARIS, France, 75010 | |
Contact: Jean-Denis LAREDO, MD;Pr +331 4995 9106 jean-denis.laredo@lrb.aphp.fr |
Principal Investigator: | Jean-Denis LAREDO, MD, Pr | AP-HP Assistance Publique- Hôpitaux de Paris |
Responsible Party: | Department of clinical research and development ( Cécile JOURDAIN ) |
Study ID Numbers: | P060110, 2006-A00479-42 |
Study First Received: | September 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00749242 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Traumatic vertebral fracture Vertebroplasty Balloon kyphoplasty Bohler bracing |
Spinal Injuries Fractures, Bone Back Injuries |
Wounds and Injuries Spinal Fractures Disorders of Environmental Origin |
Spinal Injuries Fractures, Bone Back Injuries |
Wounds and Injuries Spinal Fractures Disorders of Environmental Origin |