Status:
COMPLETED
Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
DFINE Inc.
Conditions:
Osteoporosis
Vertebral Fracture
Eligibility:
All Genders
50-90 years
Brief 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 p...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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°
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01839682
Start Date
June 1 2009
End Date
July 1 2011
Last Update
April 29 2013
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048