This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
with our without brace
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.
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
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, France
Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements.
Time frame: 1 year
1° - Pain evaluation using a visual analogic scale
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
questionnaire (Eifel) for back pain evaluation
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Quality of life evaluation (QUALEFFO - Short-Form SF12).
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra
Time frame: J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Number of new vertebral fractures occurring during the one year follow-up period
Time frame: J-20 à 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: J-20 à 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
Intensity of signal with T2 sequence
Time frame: preoperative and at J360