title: Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: a case series of 26 consecutive patients.
abstract: BACKGROUND
  Minimally 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.
  
  
  METHODS
  Forty-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.
  
  
  RESULTS
  No 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).
  
  
  CONCLUSIONS
  The initial clinical experience with the Kiva System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.
authors.affiliation: Orthopaedic Department, General Hospital Agios Andreas, 1 Tsertidou str, 26224 Patras, Greece.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Korovessis
authors.forename: Thomas
authors.initials: T
authors.lastname: Repantis
authors.forename: Larry E
authors.initials: LE
authors.lastname: Miller
authors.forename: Jon E
authors.initials: JE
authors.lastname: Block
mesh_terms: D000368:Aged; D001843:Bone Cements; D002484:Cementation; D004185:Disability Evaluation; D005240:Feasibility Studies; D005260:Female; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D058866:Osteoporotic Fractures; D010146:Pain; D010147:Pain Measurement; D011183:Postoperative Complications; D020127:Recovery of Function; D016103:Spinal Fractures / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D001843:Bone Cements