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

Primary Purpose

Spinal Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
standard vertebroplasty
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fractures focused on measuring spinal fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).

Full Information

First Posted
December 21, 2007
Last Updated
August 31, 2012
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00594321
Brief Title
Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine
Acronym
EFFECTS
Official Title
Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor closed the trial before it began
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fractures
Keywords
spinal fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
1
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
Intervention Description
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
Intervention Type
Device
Intervention Name(s)
standard vertebroplasty
Intervention Description
standard vertebroplasty
Primary Outcome Measure Information:
Title
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females between 18 and 85 years of age Pain at one to three levels, or five for multiple myeloma (pain on palpation/percussion over fractured vertebral body) requiring treatment Spinal metastasis (except renal cell), myeloma, or lymphoma of the spine Pathological fracture(s), T5-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI) Visual Analog Scale (VAS) for pain of > 4 on a scale of 0 to 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 - Defined as a procedure the magnitude of a laminectomy or more 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 Pathological vertebral fracture with 20-70% compression (compared to adjacent normal vertebral body) Fracture age < 6 months Signal on MRI 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 other than plasmacytoma Renal cell tumors More than 80% compression of the vertebrae Level(s) above T7 to treat Fractures due osteoporosis Burst fracture Pedicle fracture Neurological deficit associated with the fracture 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 High energy trauma Severe cardiopulmonary deficiencies - Defined as not being able to tolerate general anesthesia (although the likelihood is local anesthesia will be used) Vertebra plana defined as vertebral body height of 20% or less compared to the nearest normal level Disabling back pain secondary to another cause that may interfere with accurate data collection Subjects who are known to be pregnant (pregnancy test required within 10 days of treatment) or lactating Females capable of reproduction and will not take acceptable measures to prevent reproduction during the study Subjects who test positive for HIV 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) Lesions involving the pedicle Platelet count of < 50,000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur B. Dublin, M.D.
Organizational Affiliation
UC Davis Dept. of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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

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