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: * decreased morbidity due to suppression of the anterior surgery * improve final spine alignment and vertebral Kyphotic angle avoiding the loss in kyphotic angle which often occurs between the posterior and anterior surgery with the conventional two session surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
17
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
Service de Radiologie, Hôpital Lariboisière
Paris, France
Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements
Time frame: 1 year
Pain evaluation using a visual analogic scale
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
EIFEL questionnaire for back pain evaluation
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Quality of life evaluation (SF 12).
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle.
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra.
Time frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Number of new vertebral fractures occurring during the one year follow-up period.
Time frame: 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
Time frame: 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
Time frame: preoperative, at J6 and at J360
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