Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00594321

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

MedlinePlus related topics: Cancer Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

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 ]

Estimated Enrollment:	30
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator 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
1: Experimental 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:

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

Contacts and Locations

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

Responsible Party:	University of California, Davis Dept. of Radiology ( Arthur Dublin, M.D. )
Study ID Numbers:	200715482
Study First Received:	December 21, 2007
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00594321
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of California, Davis:

spinal fractures

Study placed in the following topic categories:

Spinal Injuries
Fractures, Bone
Back Injuries

Wounds and Injuries
Spinal Fractures
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009