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the number of patients recruited at present is sufficient for analysis.
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.
Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.
Patients with traumatic vertebral fractures type A3.2, A3.3, B1 and C1 of the MAGERL classification will be enrolled in this open study. They will be operated on in emergency to perform spinal canal decompression, fracture reduction and posterior fixation using fixation plates with pedicular screws combined with bone graft.
During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength.Patients will be followed up for one year.
Expected advantages of this management compared the conventional two session surgery include the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Balloon kyphoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon kyphoplasty | Device | During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation using a visual analogic scale | J-20 to J-7 - J6 - J45 - J90 - J180 - J360 | |
| EIFEL questionnaire for back pain evaluation | J-20 to J-7 - J6 - J45 - J90 - J180 - J360 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Denis LAREDO, M.D.,PR. | AP/HP Assistance Publique-Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Radiologie, Hôpital Lariboisière | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D058498 | Kyphoplasty |
| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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|
| Quality of life evaluation (SF 12). |
| J-20 to J-7 - J6 - J45 - J90 - J180 - J360 |
| Analgesics intake according to the WHO classification (Classes 1, 2 and 3). | J-20 to J-7 - J6 - J45 - J90 - J180 - J360 |
| Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle. | J-20 to J-7 - J6 - J45 - J90 - J180 - J360 |
| Changes in anterior, mid and posterior vertebral heights of the treated vertebral body | J-20 to J-7 - J6 - J45 - J90 - J180 - J360 |
| Changes in height of the intervertebral disc spaces adjacent to the treated vertebra. | J-20 to J-7 - J6 - J45 - J90 - J180 - J360 |
| Number of new vertebral fractures occurring during the one year follow-up period. | J-20 to 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 | J-20 to 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 | preoperative, at J6 and at J360 |
| D013514 |
| Surgical Procedures, Operative |