Painful Osteoporotic Vertebral Compression Fractures (VCF) Clinical Trial
Official title:
Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation (The PRIORi-T Trial)
The objective of this post market clinical investigation is to evaluate the clinical effectiveness of a minimally invasive vertebral augmentation procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful osteoporotic vertebral compression fractures (VCF).
This is a multi-center, prospective, randomized, post marketing clinical trial designed to
evaluate the clinical effectiveness of a minimally invasive procedure,
Radiofrequency-Targeted Vertebral Augmentation (RF-TVA), compared to Non Operative
Management (NOM) for the treatment of appropriately diagnosed, acute (≤ 8 weeks), painful,
osteoporotic vertebral compression fractures. Eligible subjects will be randomly allocated
to receive either RF-TVA or NOM in a 1:1 randomization ratio. Subjects will be followed for
12 months post procedure. Primary effectiveness will be determined by comparing the Visual
Analogue Scale for each treatment group for back pain from the baseline to the 1-month post
procedure visit and between treatment groups at 1-month.
Up to 15 sites will participate in this trial.
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