Osteoporosis Clinical Trial
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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