Clinical trial: Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis (NCT01839682)

Eligibility criteria:
Inclusion Criteria:

          -  Males and females 50-90 years of age

          -  Pain on palpation/percussion over fractured vertebral body at one to three levels that
             require treatment

          -  Compression fracture(s), T10 to L5, with bone marrow edema imaged by magnetic
             resonance imaging (MRI)

          -  Visual Analog Scale (VAS) for pain >4 on a scale of 0-10

          -  Oswestry score of at least a moderate disability (21-40%)

          -  No major surgery to the spine planned for at least 1 month following enrollment

          -  Life expectancy of > 6 months

          -  Patient has sufficient mental capacity to comply with the protocol requirements

          -  Availability for all study visits and phone calls

          -  Understands the potential risks and benefits of participating in the study and is
             willing to provide written informed consent.

          -  Vertebral compression fracture with 20-90% compression (compared to adjacent normal
             vertebral body)

          -  Fracture age < 6 months

          -  Signal on MRI or bone scan consistent with non-healed fracture

          -  Female subjects must either be no longer capable of reproduction or taking acceptable
             measures to prevent pregnancy during the study

          -  Subject must be willing and able to comply with specified follow-up evaluations

        Exclusion Criteria:

          -  Primary tumors and spinal metastasis, myeloma, or lymphoma of the spine

          -  More than 90% compression of the vertebrae

          -  Level(s) above T10

          -  Pedicle fracture

          -  Neurologic deficit associated with the level(s) to be treated

          -  Kyphosis > 30°

          -  Translation > 4 mm

          -  Instability of posterior wall with symptomatic displacement of fragment into spinal
             canal or significant canal compromise

          -  Intercostal nerve compression

          -  Active systemic or local infection at the level(s) to be treated

          -  Myelopathy

          -  Uncontrolled coagulopathy

          -  Cannot temporarily discontinue anticoagulation therapy

          -  Known allergy to device materials / PMMA

          -  Radiculopathy

          -  Cord compression or canal compromise requiring surgery for decompression

          -  Fracture due to high energy trauma

          -  Severe cardiopulmonary deficiencies

          -  Vertebra-plana

          -  Disabling back pain secondary to another cause that may interfere with accurate data
             collection

          -  Subjects who are known to be pregnant (pregnancy test required within10 days of
             treatment or lactating

          -  Females capable of reproduction and will not take acceptable measures to prevent
             reproduction during the study

          -  Currently enrolled in an investigational device (IDE) that has not completed the
             protocol required primary follow-up period (excludes 15 year follow-up of gene therapy
             trials)

          -  Lesions involving the pedicle
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years

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

Does the patient match the trial criteria? 1