Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

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

- Identified painful VCF has at least superior and one normal vertebrae within 2
levels inferior.

- Either the immediate superior OR the immediate inferior vertebral body (but not
both) may have a chronic fracture that does not need treatment.

- 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