Kiva VCF Treatment System
Dr. Budler of Bryan Medical Center recently became the first doctor in Nebraska to use the new implant, “Kiva” to treat a patient’s spine vertebral fracture. Cleared by the Food and Drug Administration in January 2015, The Kiva System is the first clincally proven approach for the treatment of VCFs in more than a decade. The Kiva System uses a cylindrical implant that is delivered through a single incision no wider than a traditional ballpoint pen. The implant is designed to provide a predictable structural support to the vertebral body, and direct and contain the bone cement that is used to repair VCFs.
In clinical trials, the minimally invasive Kiva System was shown to meet or exceed the performance of balloon kyphoplasty– the current standard of care for the treatment of VCFs. In one or more of these studies, patients who received Kiva experienced the same pain relief and functional improvement, but Kiva patients were less likely to have the bone cement leak, less likely to suffer another fracture in adjacent vertebra and more likely to have the natural alignment of their spine restored.
The Kiva System has been proven to:
- Reduce rate of adjacent level fractures
- Improve kyphotic angel restoration
- Reduce rate of cement extravasation
- Reduce cement volume
For patients with a spinal fracture who are experiencing pain, a minimally invasive procedure known as a kyphoplasty can stabilize the bone involved, restore some or all of the lost vertebral body height that resulted from the fracture, as well as markedly reduce the back pain. It is performed with a local anesthetic and I.V. conscious sedation. It usually takes 30 minutes and the patient may often return home the same day.
Kyphoplasty begins with 1 or 2 small incisions made in the back. The interventional radiologist places needles into the fractured vertebral body. Inflatable balloons are placed through the needles and into the fractured vertebral body utilizing real-time x-ray guidance. As the balloons are carefully inflated, the vertebral body height is raised to a more normal alignment. Doing this also compacts the soft inner bone, creating a cavity inside the vertebral body. The balloons are then withdrawn. The doctor fills the cavity with a special polymethylmethacrylate(PMMA) called Activos10, which allows for better bone growth into the cement. Shortly after application, the PMMA quickly hardens, stabilizing the bone and decreasing the risk of a refracture. Dr. Budler has been performing kyphoplasties since 2003 and ranks in the top 2% in the country for numbers of kyphoplasty procedures performed.
More information is available here.
A vertebroplasty is a minimally invasive surgery performed through 1 or 2 small nicks in the skin with the purpose of stabilizing a spinal compression fracture and decreasing the pain caused by the fracture. In contrast to kyphoplasty, no balloons are utilized during this procedure.
Vertebroplasty is performed under local anesthetic and I.V. sedation on an outpatient basis. In the procedure, needles placed into the fractured vertebral body via x-ray guidance. A specialized bone cement is injected into the fractured vertebral body, creating a stabilizing cast within the bone. The cement takes approximately 10 minutes to become rock solid. In all, the entire procedure usually takes around 30 minutes to complete and the pain of the fracture is alleviated shortly afterward.
A sacroplasty is a minimally invasive procedure that can relieve lower back and pelvic pain associated with fractures of the sacrum. Using local anesthetic and I.V. conscious sedation, real-time CT or X-ray imaging is used to help guide the needles into the sacrum. Bone cement is then injected into the fracture sites through the needles, stabilizing the bone and decreasing the pain.