Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

PHASE4CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Vertebral Compression Fracture
Interventions
DEVICE

Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Trial Locations (1)

10021

Hospital for Special Surgery, New York

All Listed Sponsors
lead

Hospital for Special Surgery, New York

OTHER

NCT01383616 - Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures | Biotech Hunter | Biotech Hunter