Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Spine LLC
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
