OsteoporosisNCT01839682
Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis
An observational study of Osteoporosis and Vertebral Fracture, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoporosis, Vertebral Fracture
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2011
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients evaluated for vertebral compression fracture in clinic
Who may be able to join
- Males and females 50-90 years of age
- Pain on palpation/percussion over fractured vertebral body at one to three levels that require treatment
- Compression fracture(s), T10 to L5, with bone marrow edema imaged by magnetic resonance imaging (MRI)
- Visual Analog Scale (VAS) for pain >4 on a scale of 0-10
- Oswestry score of at least a moderate disability (21-40%)
- No major surgery to the spine planned for at least 1 month following enrollment
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- 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.
- Vertebral compression fracture with 20-90% compression (compared to adjacent normal vertebral body)
- Fracture age < 6 months
- Signal on MRI or bone scan 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 and spinal metastasis, myeloma, or lymphoma of the spine
- More than 90% compression of the vertebrae
- Level(s) above T10
- Pedicle fracture
- Neurologic deficit associated with the level(s) to be treated
- Kyphosis > 30°
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- 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
- Fracture due to high energy trauma
- Severe cardiopulmonary deficiencies
- Vertebra-plana
- Disabling back pain secondary to another cause that may interfere with accurate data collection
- Subjects who are known to be pregnant (pregnancy test required within10 days of treatment or lactating
- Females capable of reproduction and will not take acceptable measures to prevent reproduction during the study
- Currently enrolled in an investigational device (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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Prospective, Single Arm, Open Label Post-Market Pilot Study to Evaluate the StabiliT Vertebral Augmentation System Treat Vertebral Compression Fractures Due to Osteoporosis
This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral compression fractures.
Read the detailed description
This is a single arm, post market surveillance pilot study of an FDA cleared product, to evaluate the procedural and clinical profile of an ultra high viscosity cement vertebral augmentation system for the treatment of vertebral compression vertebral fractures due to osteoporosis.
Twenty (20) consenting evaluable adult male and female patients between the ages of 50 and 90 who meet the inclusion criteria for the study and are treated using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement as part of their standard treatment for osteoporotic vertebral compression fractures will be enrolled in the study.
The participants will be followed after the procedure for 3 months by telephone and/or mailed questionnaire by an IRB certified member of the research team. Information collected will include the patient's ability to ambulate independently and activity level pre and post-treatment, decrease or increase in pain level compared to pre-treatment, and monitoring adverse events. Data will be collected at enrollment, procedure, discharge (or 1 day post procedure), 1 week, 1 month and 3 months post procedure using the Visual Analog Scale (VAS) for pain score, Oswestry Disability Index. Standard of care radiographs and MRI or CT/bone scan are evaluated by a board certified radiologist. The data collected will be compared to measure outcomes.
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- StabiliT, Kyphoplasty, Vertebral, Compression, Fracture, Osteoporosis
- Medical subject headings
- Osteoporosis, Spinal Fractures, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes in pain
Pain will be assessed using the Visual Assessment Scale (VAS) at enrollment, and interval changes captured at discharge (or 1 day), 1 week, 1 month and 3 months post procedure. Pre and post procedure pain will be compared.
Measured: Enrollment, discharge (or 1 day), 1 week, 1 month, 3 month post procedure
Secondary outcomes (1)
Assess changes in mobility.
Assess changes in mobility using the Oswestry Disability Index pre to capture interval changes at enrollment, and at 1 month and 3 months post procedure.
Measured: Enrollment, 1 month and 3 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DFINE Inc.
- Responsible party
- Principal investigator, Franklin G. Moser, M.D., Cedars-Sinai Medical Center
- Investigators
- Franklin G. Moser, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839682
- Sponsor's protocol ID
- Siegel-1
- Other IDs
- 00017253
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chin DK, Park JY, Yoon YS, Kuh SU, Jin BH, Kim KS, Cho YE. Prevalence of osteoporosis in patients requiring spine surgery: incidence and significance of osteoporosis in spine disease. Osteoporos Int. 2007 Sep;18(9):1219-24. doi: 10.1007/s00198-007-0370-8. Epub 2007 Mar 27.
PubMed 17387420Ledlie JT, Renfro MB. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine (Phila Pa 1976). 2006 Jan 1;31(1):57-64. doi: 10.1097/01.brs.0000192687.07392.f1.
PubMed 16395177
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Open Label Post-Market Pilot Study to Evaluate the StabiliT Vertebral Augmentation System Treat Vertebral Compression Fractures Due to Osteoporosis
- ClinicalTrials.gov ID
- NCT01839682
- Acronym / sponsor ID
- Siegel-1
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- StabiliT, Kyphoplasty, Vertebral, Compression, Fracture, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- DFINE Inc.
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Apr 2013 (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.
This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral compression fractures.
Detailed description
This is a single arm, post market surveillance pilot study of an FDA cleared product, to evaluate the procedural and clinical profile of an ultra high viscosity cement vertebral augmentation system for the treatment of vertebral compression vertebral fractures due to osteoporosis.
Twenty (20) consenting evaluable adult male and female patients between the ages of 50 and 90 who meet the inclusion criteria for the study and are treated using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement as part of their standard treatment for osteoporotic vertebral compression fractures will be enrolled in the study.
The participants will be followed after the procedure for 3 months by telephone and/or mailed questionnaire by an IRB certified member of the research team. Information collected will include the patient's ability to ambulate independently and activity level pre and post-treatment, decrease or increase in pain level compared to pre-treatment, and monitoring adverse events. Data will be collected at enrollment, procedure, discharge (or 1 day post procedure), 1 week, 1 month and 3 months post procedure using the Visual Analog Scale (VAS) for pain score, Oswestry Disability Index. Standard of care radiographs and MRI or CT/bone scan are evaluated by a board certified radiologist. The data collected will be compared to measure outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients evaluated for vertebral compression fracture in clinic
Key inclusion criteria (15 listed)
- Males and females 50-90 years of age
- Pain on palpation/percussion over fractured vertebral body at one to three levels that require treatment
- Compression fracture(s), T10 to L5, with bone marrow edema imaged by magnetic resonance imaging (MRI)
- Visual Analog Scale (VAS) for pain >4 on a scale of 0-10
- Oswestry score of at least a moderate disability (21-40%)
Key exclusion criteria (24 listed)
- Primary tumors and spinal metastasis, myeloma, or lymphoma of the spine
- More than 90% compression of the vertebrae
- Level(s) above T10
- Pedicle fracture
- Neurologic deficit associated with the level(s) to be treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure changes in pain
Time frame: Enrollment, discharge (or 1 day), 1 week, 1 month, 3 month post procedure
Pain will be assessed using the Visual Assessment Scale (VAS) at enrollment, and interval changes captured at discharge (or 1 day), 1 week, 1 month and 3 months post procedure. Pre and post procedure pain will be compared.
1 secondary outcome
Assess changes in mobility.
Time frame: Enrollment, 1 month and 3 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
- Background: PubMed 17387420Chin DK, Park JY, Yoon YS, Kuh SU, Jin BH, Kim KS, Cho YE. Prevalence of osteoporosis in patients requiring spine surgery: incidence and significance of osteoporosis in spine disease. Osteoporos Int. 2007 Sep;18(9):1219-24. doi: 10.1007/s00198-007-0370-8. Epub 2007 Mar 27.
- Background: PubMed 16395177Ledlie JT, Renfro MB. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine (Phila Pa 1976). 2006 Jan 1;31(1):57-64. doi: 10.1097/01.brs.0000192687.07392.f1.
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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.
Franklin G. Moser, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Vertebral Fracture, run by Cedars-Sinai Medical Center 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 15 inclusion and 24 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: finished, as of the sponsor's last update on 29 Apr 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure changes in pain (time frame: Enrollment, discharge (or 1 day), 1 week, 1 month, 3 month post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839682, which also lists 2 linked publications.
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 29 Apr 2013.