BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study.FDA device/drug status: The devices are FDA approved or approved by corresponding national agencies for this indication. The SpineJack Ò is commercially available in Europe. KyphX Xpander Ò Inflatable Bone Tamp is commercially available in the United States and Europe.

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