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

This study has been withdrawn prior to enrollment.
(Sponsor closed the trial before it began)
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00594321
First received: December 21, 2007
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

The objective of the clinical trial is to evaluate the SPACE 360 Delivery System using SPACE CpsXL Bone Cement compared to standard vertebroplasty in the treatment of pathological fractures of the spine caused by metastatic tumors of the spine, myeloma, or lymphoma. Up to a total of three levels per patient may be included or five levels for multiple myeloma. The control group will be standard vertebroplasty.


Condition Intervention
Spinal Fractures
Device: SPACE CpsXL Bone Cement and SPACE 360 Delivery System
Device: standard vertebroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Subjects randomized to the control arm of the study will have a standard vertebroplasty with any FDA-approved bone cement done in accordance with the usual method employed by the treating physician.
Device: standard vertebroplasty
standard vertebroplasty
Experimental: 1
Subjects randomized to the experimental arm of the study will have a vertebroplasty with the SPACE CpsXL Bone cement (FDA-approved) and SPACE 360 Delivery System (FDA-approved).
Device: SPACE CpsXL Bone Cement and SPACE 360 Delivery System
SPACE CpsXL Bone Cement and SPACE 360 Delivery System

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 collection
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594321

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Arthur B. Dublin, M.D. UC Davis Dept. of Radiology
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00594321     History of Changes
Other Study ID Numbers: 200715482
Study First Received: December 21, 2007
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
spinal fractures

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Back Injuries
Spinal Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014