Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures (OSTEO+6)

Inclusion Criteria:

• Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure
• Patient has read and sign the informed consent
• Male or female, 50 years or older

• One or two non-traumatic vertebral fracture(s):

  • Of osteoporotic origin (low speed trauma such as fall from his own height or less than 80 cm)
  • Fracture(s) older than 6 weeks duration after the onset of pain related to the fracture· The fracture(s) exhibit(s) high signal intensity on T2-weighted images and a benign appearance at MRI
• Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
• The patient will be able to receive the selected protocol treatment within 15 days after treatment randomization.
• The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty.

Exclusion Criteria:

• Patient with a vertebral fracture of less than 6 week duration after onset of fracture-related symptoms.
• Neurological signs related to the vertebral fracture to treat
• History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
• Patient with more than 2 fractures corresponding to the inclusion criteria (old fractures are not taken into account)
• Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
• More than two recent vertebral fractures
• Current infection
• Impossibility to perform the percutaneous approach of the vertebra to treat.
• Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
• Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat.
• Vertebral fracture with loss of 90%or more of the vertebral body height
• Malignant and traumatic vertebral fractures

• Contraindication to MRI :

  • Metallic implant : pace-maker, no auditive implant , metallic vascular or AMOVIBLE cardiac device
  • Metallic surgical clips Claustrophobia
• Evolutive cardiac disease nonreactive to medical treatment
• Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
• Presence of an unexplained biological inflammatory syndrome with VS≥20
• Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.
• Pregnant or breast feeding women
• Patient not affiliated to social security