Clinical Research Directory
Browse clinical research sites, groups, and studies.
Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures
Sponsor: Spine Centre of Southern Denmark
Summary
The main purpose of this study: \- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine. Secondary purposes: * To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine. * measure if there are differences in change of lung capacity between the two methods
Official title: Percutaneous Vertebroplasty Opposite - Infiltration of the Periost and Vertebral Body With Lidocaine - as Pain Palliative Treatment of Osteoporotic Vertebral Fractures of the Thoracic and Lumbar Spine
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2012-02
Completion Date
2015-04
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Middelfart Spinesurgery research department
Middelfart, Region Syddanmark, Denmark