Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures

NACompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2015

Conditions
Osteoporotic Fractures
Interventions
PROCEDURE

Percutaneous vertebroplasty

Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.

PROCEDURE

Lidocaine injection

Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure.

Trial Locations (1)

5500

Middelfart Spinesurgery research department, Middelfart

All Listed Sponsors
collaborator

Odense University Hospital

OTHER

lead

Spine Centre of Southern Denmark

OTHER

NCT01537770 - Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures | Biotech Hunter | Biotech Hunter