Abstract
BackgroundMinimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation.MethodsForty-two vertebral fractures were identified in 26 consecutive patients (mean age 74 ± 9 years). All patients were treated with a novel percutaneous vertebral augmentation device (Kiva® VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA). Indications for surgery included recent (≤ 3 months) symptomatic osteoporotic vertebral fracture (n = 34) and pathologic vertebral fractures (e.g. metabolic bone disease, myeloma, metastasis) (n = 8) located between T10 and S1. Patient outcomes were evaluated pre-treatment and at 2- and 6-month follow-up visits. Postoperative cement extravasation was assessed with computed tomography. Patient-reported back pain was quantified using an 11-point numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index on a 0 to 100% scale.ResultsNo cases of intraoperative hypotension, respiratory disturbance, neurological deterioration, infection, or death were observed. There were 2 (4.8%) levels where anterior cement leakage was visible radiographically in patients with osteolyses. No intracanal leakage was observed. Back pain scores improved 71% (p < 0.001) from pre-treatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001).ConclusionsThe initial clinical experience with the Kiva® System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.
Highlights
Invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures procedural polymethylmethacrylate cement leakage remains common
Symptomatic vertebral compression fractures are initially treated with conservative care
We report our initial experience with a novel vertebral augmentation system designed to treat painful vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation
Summary
Invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures procedural polymethylmethacrylate cement leakage remains common. We report our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation. Vertebral compression fractures are common injuries with an incidence of 1.4 million each year [1]. Manifestations of fractured vertebrae include severe chronic back pain, disability, and reductions in quality of life [2,3,4,5,6,7] as well as greater risk for future vertebral fractures [8]. Symptomatic vertebral compression fractures are initially treated with conservative care, report our initial experience with a novel vertebral augmentation system designed to treat painful vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation
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