Spinal FracturesEFFECTSNCT00594321
Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine
A study testing SPACE CpsXL Bone Cement and SPACE 360 Delivery System and standard vertebroplasty in people with Spinal Fractures, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- SPACE CpsXL Bone Cement and SPACE 360 Delivery System and standard vertebroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
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.
Read the 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).
- Conditions
- Spinal Fractures
- Being tested
- SPACE CpsXL Bone Cement and SPACE 360 Delivery System, standard vertebroplasty
- Keywords
- spinal fractures
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPACE CpsXL Bone Cement and SPACE 360 Delivery SystemDevice
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
standard vertebroplastyDevice
standard vertebroplasty
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 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). Receives: Device: SPACE CpsXL Bone Cement and SPACE 360 Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.
Measured: 3 years
Secondary outcomes (1)
Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Sponsor closed the trial before it began
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur B. Dublin, M.D., Principal investigator, UC Davis Dept. of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594321
- Sponsor's protocol ID
- 200715482
- Acronym
- EFFECTS
- Status last verified
- Aug 2012
- First submitted
- 21 Dec 2007
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine
- ClinicalTrials.gov ID
- NCT00594321
- Acronym / sponsor ID
- EFFECTS / 200715482
- Conditions
- Spinal Fractures
- Keywords
- spinal fractures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor closed the trial before it began
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Device: standard vertebroplastySubjects 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. |
| 1 | Experimental | Device: SPACE CpsXL Bone Cement and SPACE 360 Delivery SystemSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (29 listed)
- Primary tumors other than plasmacytoma
- Renal cell tumors
- More than 80% compression of the vertebrae
- Level(s) above T7 to treat
- Fractures due osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPACE CpsXL Bone Cement and SPACE 360 Delivery SystemSPACE CpsXL Bone Cement and SPACE 360 Delivery System | Device | 1 |
| standard vertebroplastystandard vertebroplasty | Device | 2 |
Primary outcome
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.
Time frame: 3 years
1 secondary outcome
Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur B. Dublin, M.D. principal investigator
UC Davis Dept. of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPACE CpsXL Bone Cement and SPACE 360 Delivery System and standard vertebroplasty in people with Spinal Fractures, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.