Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Condition: Vertebral Body Compression Fractures (VCFs)
MeSH terms: Fractures, Compression
Intervention: Kyphon® Curette
Intervention description: The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The objective of this study is to measure the effect that the scraping and scoring of
      vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height
      restoration and angular deformity correction during a balloon kyphoplasty procedure.
    

Eligibility criteria:

        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