Clinical trial: Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures (NCT00749086)

Eligibility criteria:
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 movable
                  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman

Does the patient match the trial criteria? 1