Clinical trial: Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients (NCT00933036)

Eligibility criteria:
Inclusion Criteria:

          1. Patient is at least 50 years old.

          2. Patient must have a fracture due to diagnosed or presumed underlying primary or
             secondary osteoporosis (Patients with AO type A1 fractures (all) may be included in
             the study).

          3. Patient must have confirmed acute pain and tenderness over the spine at or near the
             level of x-ray compression deformity OR positive MRI evaluation.

          4. Patient must NOT have more than (3) three vertebral compression fractures located
             between T4 and L5.

          5. Subjects affected vertebral body must have a loss of 0- 50% in vertebral height as
             compared with the height of an adjacent normal vertebral body confirmed by
             radiological evaluation.

          6. Subject fracture is confirmed by MRI imaging including T1, T2 and STIR-weighted
             studies to determine the type and presence of fracture(s).

          7. Subjects affected vertebral body height and geometry is adequate for insertion of
             access instruments of 5.2mm OD, as determined by the investigator.

          8. Subjects pain score is equal to or greater than 5 according to the visual analog scale
             (VAS).

          9. Patient has been evaluated for hematologic disorders or other conditions affecting
             blood coagulation.

         10. Subjects are suitable candidates for standard vertebroplasty or kyphoplasty
             procedures.

         11. Subject is psychosocially, mentally, and physically able to fully comply with this
             protocol including adhering to scheduled visits, treatment plans, completing forms,
             and other study procedures.

         12. Subject signed the Informed Consent Form prior to any study related procedures
             indicating that he/she has been informed of all pertinent aspects of the trial.

         13. Failure of conservative treatment prior to inclusion: a. failed conservative treatment
             arm; b. acute therapy treatment arm.

        Exclusion Criteria:

          1. Patient has significant vertebral collapse, defined as > 50% of the original height of
             the vertebral body, as measured against the nearest normal vertebral body. Degree of
             collapse will be determined by using the height of the nearest normal vertebral body
             to represent 100% and dividing the height of the collapsed vertebral body by the
             height of the normal vertebral body.

          2. Patient has compromised spinal canal.

          3. Patient has symptomatic spinal stenosis.

          4. Patient has painful VCF with fracture age greater than 6 months.

          5. Patients has primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma
             at site of the index VCF. Patients with these tumors in anatomic sites other than the
             index VCF are eligible.

          6. Patient has a fracture that extends into the posterior vertebral body wall.

          7. Patient has neurological compromise (including myelopathy) and instability

          8. Patient has a retropulsion severe enough to cause myelopathy, unless prior surgical
             decompression is performed.

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

         10. Patient requires the use of high-dose steroid, IV pain medication, or nerve block to
             control chronic back pain unrelated to index VCF(s). Patients who receive high-dose
             steroids for treatment of their cancer (for at least 30 days) are eligible.

         11. Patient who may require allogenic bone marrow transplantation during the course of the
             study.

         12. Patient is in need of an open decompression.

         13. Patient with burst fracture, and/or pedicle fracture at the treatment level.

         14. Patient with a known or suspected allergy to PMMA or allergy to any device material
             used in the treatment of vertebral fractures. Note that in subjects with allergy to
             iodine-based contrast, other non-iodine contrast solutions may be used.

         15. Patient does not have local pain and tenderness that correlates with MRI evaluation.

         16. Patient has a coagulation disorder that cannot be corrected: a. for patients with
             hematologic disorders or other conditions affecting blood coagulation, a platelet
             count and internationalized normal ratio (INR), prothrombin time (PT), and partial
             thromboplastin time (PTT) values should be available at time intervals typical of the
             treatment center. The Investigator is to evaluate the ranges relative to the normal
             values of the treatment center laboratory.

         17. Patient has an active local or systemic infection.

         18. Patient has a previous or current treatment for cancer at the affected level.

         19. Patient has a previous spine surgery or previous injection of cement at the vertebral
             levels of the surgical procedure.

         20. Patient has diabetes mellitus.

         21. Patient has an MRI contraindication (e.g., cerebral aneurysm clips, pacemaker,
             implanted biostimulators, cochlear implants, penile prosthesis)

         22. Patient has an unstable spine as indicated by neurologic deficit, kyphosis greater
             than 30°, compression greater than 60%, translation greater than 4 mm,
             interspinous-process widening.

         23. Pre-existing conditions contrary to either PVA or vertebroplasty, such as: a.
             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; b. Any evidence of VB or systemic infection.

         24. Patient has a mental deficiency (e.g., psychiatric disorders, Alzheimer's disease,
             presence of alcohol or drug abuse).

         25. Patient is pregnant or is interested in becoming pregnant during the study duration.

         26. Patient is a prisoner or ward of the state.

         27. Patient expects to relocate more than 50 miles from the study center prior to
             completion of the study follow-up period.

         28. Patient has an AO classification A2, A3, B or C type fracture

         29. Patient has hemangioma, malignant fracture, and/or multiple myeloma at the site of the
             index VCF.
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.


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? Entailment