Clinical trial: KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures (NCT00323609)

Eligibility criteria:
Inclusion Criteria

        All subjects must meet all of the following criteria to be enrolled into the study:

          1. Age > 21

          2. 1 to 3 target VCFs meeting the following criteria:

               1. Fracture due to diagnosed or presumed underlying primary or secondary
                  osteoporosis

               2. All target VCFs are between T5 and L5

               3. All target VCFs to be treated show either: i. Height change: An acute (< 6 month)
                  change in VB height or morphology from a previous x-ray, CT or MRI, with height
                  loss at the anterior, middle or posterior portion of the VB consistent with a
                  worsening of 1 or more grades by the Genant criteria (17), OR ii. Positive MRI or
                  bone scan: VB shows hyperintense signal on STIR sequence MRI or target VB is
                  positive on radionuclide bone scan

               4. All VCFs to be treated have fracture age (time from pain onset to evaluation by
                  the Investigator) of 6 months or less

               5. Back pain correlating with the location of at least one VCF

          3. Treatment of all target VCFs is technically feasible by and clinically appropriate for
             BOTH vertebroplasty and balloon kyphoplasty. (Team approach only: Both the
             vertebroplasty and balloon kyphoplasty physician have reviewed radiographic studies
             and agree to this prior to enrolling the subject in the study.)

          4. Pre-treatment back pain by numerical rating scale (NRS) score > 4 (0-10 scale)

          5. Pre-treatment Oswestry Disability Index >20 (0 - 100 scale)

          6. Subject states availability for all study visits

          7. Subject is able to understand the risks and benefits of participating in the study and
             is willing to provide written informed consent

          8. Subject has mental capacity to comply with the protocol requirements for 2-year
             duration of study

        Exclusion Criteria

        Subjects who meet any of the following conditions may not be enrolled into the study:

          1. VB morphology or configuration is such that either balloon kyphoplasty OR
             vertebroplasty is not technically feasible for the targeted VCFs

          2. Fracture due to high-energy trauma

          3. Suspected OR proven cancer inside index vertebral body. Note that patients with
             chemotherapy-related osteoporosis may be included.

          4. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac
             fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)

          5. Any painful VCF with fracture age > 6 months

          6. Any objective evidence of neurologic compromise at baseline

          7. Previous balloon kyphoplasty or vertebroplasty for any VCF

          8. Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted
             VCFs

          9. Significant clinical comorbidity that may potentially interfere with long-term data
             collection or follow-up (e.g., dementia, severe comorbid illness)

         10. Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such
             as:

               1. Irreversible coagulopathy or bleeding disorder. Note regarding reversible
                  coagulopathies: Subjects on coumadin or other anticoagulants may participate.
                  Investigators should follow routine practices for perioperative discontinuation
                  and re-initiation of anticoagulants.

               2. Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty or
                  vertebroplasty. Note that in subjects with allergy to iodine-based contrast,
                  other non-iodine contrast solutions may be used.

               3. Any evidence of VB or systemic infection

         11. Pregnant or child-bearing potential
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? 1