FREE Study - Fracture Reduction Evaluation

Inclusion Criteria:

- Minimum of one painful, acute (edema present on MRI obtained within a two weeks period
prior to enrolment) thoracic or lumbar (T5-L5) vertebral body compression fracture,
due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or
osteolytic metastatic tumors and maximum of three painful fractures requiring
treatment. (NOTE: a T2-weighted MRI should be done unless it is not available);

- Minimum of one acute fracture to be treated that has height loss > 15% of predicted
height (average height of two adjacent "normal" vertebrae) when measured at the middle
of the vertebral endplate. (NOTE: If the adjacent vertebrae are not normal, the
predicted height will be based on the height listed for the fractured vertebra in the
table taken from Black et al.)

- Pre-treatment VAS score > 4 on a scale of 10 where 0 is no pain, 5 is moderate pain
and 10 is pain "as bad as you can imagine";

- Patient 21 years of age or older;

- The investigator and surgeon/radiologist agree before randomization that the
fracture(s) can technically be reduced using an inflatable bone tamp (IBT); and

- A signed Informed Consent is obtained from the patient.

Exclusion Criteria:

- Previous vertebroplasty;

- Vertebral body fracture morphology prevents use of devices (such as endplate below
pedicles);

- Pedicle fractures;

- Acute fracture(s) to be treated symptomatic > 3 months at enrollment;

- Pre-existing (not the result of the index fracture) neurological deficit or radicular
pain that is not well defined or unstable;

- Spinal cord compression or canal compromise requiring decompression;

- Disabling back pain secondary to causes other than acute fracture;

- Vertebral fracture due to primary or osteoblastic tumors;

- Patient is currently on anticoagulation therapy that can not be interrupted;

- Pre-existing conditions contrary to the kyphoplasty procedure:

- Systemic infection

- Local fractured vertebral body infection

- Temporarily non-reversible bleeding disorder

- Known allergy to any of the drugs, bone void filler material or contrast medium used
in the treatment of study subjects

- Dementia and/or inability to give informed consent;

- Inability to walk or stand prior to the vertebral body fracture (walking aids are
allowed);

- MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted
biostimulators, cochlear implants, penile prosthesis);

- Pregnancy

- Participation in any other clinical trial within the last 30 days.