FREE Study - Fracture Reduction Evaluation

An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures

The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.

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.