Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis

Completed

Conditions studied: Osteoporosis, Vertebral Fracture

In brief

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.

Key facts

Study ID

NCT01839682

Run by

Cedars-Sinai Medical Center

People needed

23

Starts

2009-06-01

Expected to finish

2011-07-01

Last updated by the study team

2013-04-29

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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