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.