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Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

18 Years
Not Enrolling
Spinal Fractures

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Trial Information

Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

The primary endpoint is cement leakage as determined radiographically (CT). will be cement
leakage measured by CT. Secondary endpoints are reduction of pain (VAS) and quality of life
measurements (Oswestry disability index).

Inclusion Criteria:

1. Males and females between 18 and 85 years of age

2. Pain at one to three levels, or five for multiple myeloma (pain on
palpation/percussion over fractured vertebral body) requiring treatment

3. Spinal metastasis (except renal cell), myeloma, or lymphoma of the spine

4. Pathological fracture(s), T5-L5, with bone marrow edema imaged by magnetic resonance
imaging (MRI)

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

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

7. No major surgery to the spine planned for at least 1 month following enrollment -
Defined as a procedure the magnitude of a laminectomy or more

8. Life expectancy of > 6 months.

9. Patient has sufficient mental capacity to comply with the protocol requirements

10. Availability for all study visits and phone calls

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

12. Pathological vertebral fracture with 20-70% compression (compared to adjacent normal
vertebral body)

13. Fracture age < 6 months

14. Signal on MRI consistent with non-healed fracture

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

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

Exclusion Criteria:

1. Primary tumors other than plasmacytoma

2. Renal cell tumors

3. More than 80% compression of the vertebrae

4. Level(s) above T7 to treat

5. Fractures due osteoporosis

6. Burst fracture

7. Pedicle fracture

8. Neurological deficit associated with the fracture

9. Kyphosis > 30°

10. Translation > 4 mm

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

12. Intercostal nerve compression

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

14. Myelopathy

15. Uncontrolled coagulopathy

16. Cannot temporarily discontinue anticoagulation therapy

17. Known allergy to device materials / PMMA

18. Radiculopathy

19. Cord compression or canal compromise requiring surgery for decompression

20. High energy trauma

21. Severe cardiopulmonary deficiencies - Defined as not being able to tolerate general
anesthesia (although the likelihood is local anesthesia will be used)

22. Vertebra plana defined as vertebral body height of 20% or less compared to the
nearest normal level

23. Disabling back pain secondary to another cause that may interfere with accurate data

24. Subjects who are known to be pregnant (pregnancy test required within 10 days of
treatment) or lactating

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

26. Subjects who test positive for HIV

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

28. Lesions involving the pedicle

29. Platelet count of < 50,000

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Arthur B. Dublin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UC Davis Dept. of Radiology


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

June 2009

Related Keywords:

  • Spinal Fractures
  • spinal fractures
  • Fractures, Bone
  • Spinal Fractures



UC Davis Medical Center Sacramento, California  95817