KAST Study: The Kiva System As a Vertebral Augmentation Treatment-A Safety and Effectiveness Trial: A Randomized, Noninferiority Trial Comparing the Kiva System With Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures

• Published in: Spine (Philadelphia, Pa. 1976) Vol. 40; no. 12; p. 865
• Main Authors: Tutton, Sean M, Pflugmacher, Robert, Davidian, Mark, Beall, Douglas P, Facchini, Francis R, Garfin, Steven R
• Format: Journal Article
• Language: English
• Published: United States 15.06.2015
• Subjects: Aged; Aged, 80 and over; Biomechanical Phenomena; Disability Evaluation; Europe; Female; Fracture Fixation, Internal - adverse effects; Fracture Fixation, Internal - instrumentation; Fracture Healing; Fractures, Compression - diagnosis; Fractures, Compression - physiopathology; Fractures, Compression - surgery; Humans; Kyphoplasty - adverse effects; Kyphoplasty - methods; Lumbar Vertebrae - diagnostic imaging; Lumbar Vertebrae - physiopathology; Lumbar Vertebrae - surgery; Male; North America; Osteoporotic Fractures - diagnosis; Osteoporotic Fractures - physiopathology; Osteoporotic Fractures - surgery; Pain Measurement; Pain, Postoperative - diagnosis; Pain, Postoperative - prevention & control; Prospective Studies; Prosthesis Design; Radiography; Recovery of Function; Spinal Fractures - diagnosis; Spinal Fractures - physiopathology; Spinal Fractures - surgery; Thoracic Vertebrae - diagnostic imaging; Thoracic Vertebrae - physiopathology; Thoracic Vertebrae - surgery; Time Factors; Treatment Outcome

The KAST (Kiva Safety and Effectiveness Trial) study was a pivotal, multicenter, randomized control trial for evaluation of safety and effectiveness in the treatment of patients with painful, osteoporotic vertebral compression fractures (VCFs). The objective was to demonstrate noninferiority of the...