Restore your spine
Approach back pain with a restorative solution
Each year, more than 700,000 spinal fractures, also known as vertebral compression fractures (VCFs), occur in the United States due to osteoporosis.1 Osteoporosis is a disease that causes bones to weaken and become more likely to break. Over time, bones may become so weak that mild strains, such as lifting a light object, coughing or sneezing, or turning in bed can lead to a spinal fracture.2
VCFs due to osteoporosis may initially be felt as severe back pain, which can affect mobility, activities of daily living and quality of life.234 In many cases, painful osteoporotic VCFs may lead to loss of height, hunched posture (kyphosis) and disability.2 Since having one or more VCFs increases the risk for developing another spinal fracture, it is important to get an early diagnosis and seek treatment as soon as possible.
- Sharp, sudden back pain
- Pain increases during standing or walking
- Lying on the back makes pain less intense
- Limited spinal mobility due to pain
- Do not respond to non-surgical treatment (bed rest, back brace, and/or pain medications)
Conservative therapy for VCFs includes bed rest, pain medication, muscle relaxants, external back braces and physical therapy. If there is little or no pain relief, your doctor may recommend vertebral augmentation with the SpineJack implant.
This minimally invasive procedure is done on an outpatient basis and usually requires only local anesthetic and mild sedation, helping to eliminate many of the complications that result from open surgery. In some instances, general anesthesia is advised with a short hospital stay.6
The procedure and what you can expect
Your doctor will do a physical exam and order imaging tests, such as an X-ray, MRI, CT scan or bone scan. These tests help to determine the location of the fractured vertebra, how recently the fracture occurred and whether or not vertebral augmentation with the SpineJack implant is the most appropriate treatment.
Generally, vertebral augmentation is performed while you are awake but sedated and your back is numbed with local anesthetic. Using X-ray guidance, two expandable implants are inserted into the fractured vertebra through small incisions. The implants are then expanded, restoring the vertebral anatomy and creating a cavity. The area surrounding the implants is then filled with bone cement to stabilize the fracture.7 As it hardens, the bone cement forms an internal cast that holds the vertebra in place. Following the procedure, the incisions are covered with bandages.
After the procedure, you’ll lie on your back for a short period of time while the bone cement continues to harden. Your vital signs will be monitored. Typically, patients are able to go home within a few hours of treatment. Please see the Benefits and risks section of the brochure for more information.
Implants are slowly expanded, allowing the SpineJack system to restore the height of the fractured vertebral body.7
Benefits and risks
The SpineJack system has been shown to provide improved pain relief in patients up to 12 months following the procedure. Additional benefits for patients treated with the SpineJack system include restoring vertebral body height and reducing adjacent level fractures.8
The use of the SpineJack system may directly or indirectly cause side effects or complications. Discuss the risks and benefits of the SpineJack procedure with your doctor to decide if this treatment option is right for you.
Complications related to bone cement use are rare. However, serious side effects have been known to occur with the use of bone cement in surgical procedures of the spine. These include heart attack, cardiac arrest (heart stops beating), stroke, embolism (blood clot or bone cement that moves to the heart or lungs) or death. Side effects may occur up to one year after the procedure.
Side effects related to use of the SpineJack system with bone cement include infection, bleeding, allergic reaction, thrombosis (blood clot formation), numbness or tingling and changes in blood pressure. Please consult with your doctor for the full list of possible side effects related to the combined use of bone cement with the SpineJack implant.