A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)

Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. Pros...

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Bibliographic Details
Published in:The spine journal 2019-11, Vol.19 (11), p.1782-1795
Main Authors: Noriega, David, Marcia, Stefano, Theumann, Nicolas, Blondel, Benjamin, Simon, Alexandre, Hassel, Frank, Maestretti, Gianluca, Petit, Antoine, Weidle, Patrick A., Mandly, Andres Gonzalez, Kaya, Jean-Marc, Touta, Adamou, Fuentes, Stéphane, Pflugmacher, Robert
Format: Article
Language:English
Subjects:
Adjacent fractures
Aged
Aged, 80 and over
Balloon kyphoplasty
Bone Cements - therapeutic use
Equivalence Trials as Topic
Female
Fracture Fixation, Internal - instrumentation
Fractures, Compression - diagnostic imaging
Fractures, Compression - surgery
Height restoration
Humans
Infant
Internal Fixators
Kyphoplasty - methods
Male
Middle Aged
Osteoporosis
Osteoporotic Fractures - diagnostic imaging
Osteoporotic Fractures - surgery
Pain - etiology
Pain - surgery
Percutaneous vertebral augmentation
Prospective randomized study
Prospective Studies
Quality of Life
Radiography
Spinal Fractures - diagnostic imaging
Spinal Fractures - surgery
Spine surgery
SpineJack® system
Titanium
Treatment Outcome
Vertebral compression fracture
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