Inclusion Criteria:

• Age >= 50 years

• One painful VCF meeting all of the following criteria:

  • Fracture due to diagnosed or suspected underlying primary or secondary osteoporosis
  • VCF is between T5 and L5
  • VCF shows hyperintense signal on STIR or T2 weighted MRI
  • VCF has at least 15% height loss as visualized on plain radiograph
  • Level above and level below identified VCF are not fractured (either acute or chronic)
• Patient states availability for all study visits
• Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

Exclusion Criteria:

• Patient is unable to undergo MRI
• Patient shows evidence of edema in vertebral bodies other than index level on MRI
• Patient is unable to stand for pre-operative and post-operative x-rays
• Patient body mass index (BMI) is greater than 35 kg/m2
• Patient is pregnant, or of child-bearing potential and not using contraception
• Vertebral body (VB) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index VCF
• Index fracture is result of high-energy trauma
• Suspected or proven cancer inside any VB
• Disabling back pain due to causes other than acute fracture
• Spine stabilization beyond balloon kyphoplasty required for index VCF

• Pre-existing conditions contrary to balloon kyphoplasty, such as:

  • Irreversible coagulopathy or bleeding disorder. Note that patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.
  • Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. Note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used.
  • Any evidence of VB or systemic infection