Patient Education Overview
Vertebral compression fractures are most often caused by osteoporosis, and there are 750,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone(23), representing a large patient population which is only expected to continue growing as the population ages. Other causes of VCFs include trauma and malignant bone tumors that cause the spine to collapse. VCFs are painful and debilitating.
The Kiva VCF Treatment System is indicated for the use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
The Blazer - C Vertebral Augmentation System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, malignant lesions, by creating channels in the existing spinal bone structure for the ﬂow of polymethylmethacrylate bone cement (PMMA).
As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the products listed on this site. The risks include serious complications up to and including death. Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions. Consult a healthcare provider regarding specific treatment options.
Vertebral Compression Fractures
What is a Vertebral Compression Fracture (VCF)?
Vertebral Compression Fractures (VCFs) of the spine occur when a vertebra—the bones of the spinal column—cracks, fractures, or collapses. These spinal fractures are unique because they frequently occur without apparent trauma and may cause no symptoms, often going undiagnosed until other complications arise(1). It is estimated that two-thirds of vertebral compression fractures are never diagnosed because many patients dismiss their back pain as a sign of aging and arthritis.(2)
Osteoporosis accounts for approximately 85% of all vertebral compression fractures (VCFs); trauma and malignancies make up the remainder of the cases.(3, 4, 5) When bones become fragile and brittle from osteoporosis, everyday activities can trigger minor vertebral compression fractures. Bending to lift an object or pick something up off the floor, missing a curb, or slipping on a wet surface can put the spinal bones at risk of fracture. In more severe cases of osteoporosis, coughing or sneezing can trigger a compression fracture.
Over time, these small hairline fractures permanently alter the strength and shape of the spine, eventually causing a vertebra to collapse. The pain experience of a spinal compression fracture is different for everyone. In some cases, the fractures occur so gradually that the pain is relatively mild and unnoticeable. In others, the fracture is accompanied by sudden, severe “knifelike” disabling pain in the mid-to-lower part of the spine that can take weeks or months to go away.
Without intervention the pain may subside as the fracture heals, the vertebra heals in its deformed and compressed position. This shortened, compressed vertebra alters the normal alignment of the spine, putting the spine at greater risk for subsequent fractures.(6,7) When multiple vertebral compression fractures have occurred, there is a significant change in the structure and shape of the spine.(14) This spinal deformation, called kyphosis, gives individuals a hunched-back appearance, often referred to as a “dowager hump.” Moreover, this structural change can affect the internal organs and body functions, negatively impacting the overall health of the individual and their quality of life.(8,9)
Risk Factors & Symptoms
VCFs are primarily caused by osteoporosis; however, they can also result from metastatic disease or trauma.
- Small, thin body (under 127 pounds/58 kilograms)
- Family history of osteoporosis
- Inactive lifestyle
- Post menopause or advanced age
- Rheumatoid arthritis
- Low testosterone levels in men
- A diet low in dairy products, other sources of calcium and vitamin D
- Cigarette smoking and drinking too much alcohol
- Caucasian or Asian race, but African American and Hispanic women are also at significant risk for developing the disease
- Certain medications such as steroid medications and some anticonvulsants, and others
- Certain diseases and conditions such as anorexia nervosa, rheumatoid arthritis, and gastrointestinal diseases
The symptoms associated with a vertebral compression fracture will vary considerably from individual to individual. The following list includes the most common symptoms associated with osteoporosis or cancer-related fractures:(13, 14, 15, 16)
- Sudden onset of severe, “knifelike" back pain
- Chronic or gradual onset of back pain
- Loss of height, as much as six inches over time
- Kyphosis (curved back), commonly called a dowager’s hump: altering posture in an attempt to compensate for the kyphotic deformity can affect how you walk and strain your back, neck, and joints
- Stomach complaints: a shorter spine can compress the stomach causing it to bulge and resulting in constipation, loss of appetite, and weight loss
- Hip pain: a shortened spine brings the rib cage closer the hip bones, causing pain and discomfort as these bones rub against each other
- Breathing problems: as the spine becomes severely compressed, the lungs may not function properly
Pressure on the spinal cord from kyphosis may rarely produce symptoms of:
- Difficulty walking
- Loss of control of the bowel or bladder
There are various treatment options for VCFs such as conservative care, vertebroplasty, and vertebral augmentation often referred to as kyhphoplasty.
Conservative care of VCFs relies on the use back braces, bed rest, and analgesic medications for alleviating pain. While the fracture eventually heals over time, the vertebral body remains in a collapsed, compressed state. Conservative care can result in prolonged pain, impaired function, and decreased activity. Additionally, bone and muscle loss resulting from a lack of activity can make recovery even more difficult, leading to the “downward spiral” of vertebral osteoporosis.(17)
Vertebroplasty, developed in the early 1980s in France by Deramond and Galivert and introduced in the US in the mid-1990s, consists of injecting a thin bone cement into the vertebral body under high pressure.(18,19) The vertebral body is then stabilized by cementing the fractured bone in its existing position. The primary risk of vertebroplasty is cement extravasation, or leakage of bone cement into the surrounding space.(20)
Kyphoplasty, introduced in the late 1990s, involves creating a cavity within the vertebral body by using an inflatable balloon tamp. The cavity is then filled with thicker bone cement under lower pressure in an effort to reduce the risk associated with cement leakage.(21)
Kiva is a unipedicular, PEEK-OPTIMA® implant, solution for vertebral augmentation and a departure from balloon kyphoplasty making it the first new approach to the treatment of vertebral compression fractures in over a decade.
Kiva has been demonstrated to meet or exceed the performance of balloon kyphoplasty (BKP) in three separate comparative studies 24,25,26. In one or more of these studies, as compared to BKP, Kiva was shown to:
• Reduce rate of adjacent level fracture
• Improve kyphotic angle restoration
• Reduce rate of cement extravasation
• Reduce the cement volume
The procedure can be done under local or general anesthesia – your doctor will determine which option is best for you. The procedure usually takes less than an hour per fracture treated and you may be required to stay in the hospital overnight if your doctor determines it is necessary.
FAQ's & Resources
Frequently Asked Questions
How are VCFs diagnosed?
Diagnosis of VCFs usually includes a physician exam and an x-ray. In the physical exam, your physician will examine the curvature of your spine, as well as tenderness over the affected spinal bone or bones. The spine x-ray will show whether at least one compressed vertebra is shorter than the other vertebrae. In addition, your physician may suggest a bone density test to evaluate for osteoporosis or a CT or MRI scan if there is concern that the fracture was caused by a tumor or severe trauma (such as a fall or car accident). Remember, back pain is not necessarily a normal part of aging. If you have chronic back pain, considering seeing your physician to rule out a VCF.
When should I consider a surgical treatment for VCF?
While every person is different, physicians will typically recommend surgery if you have severe and disabling pain that does not get better with other treatments.Even if the fracture heals over time with conservative (non-surgical) treatment, the vertebral body remains in a collapsed, compressed state. A conservative approach to treatment can result in prolonged pain, impaired function, and decreased activity.
How long does the Kiva procedure take? Does it require hospitalization?
The Kiva procedure usually less than an hour per treated fracture. Local or general anesthesia may be used, depending on your overall health. Your physician will also determine whether you require hospitalization, but most patients go home the same day.
What are the potential benefits of the Kiva System?
The Kiva VCF Treatment System has been shown to reduce pain and restore function for patients with VCFs.
Are there risks associated with the Kiva procedure?
As with any surgical procedure, there are possible risks and serious adverse events can happen. You will need to discuss these with your doctor. Treatment with the Kiva System is designed to minimize these risks as much as possible. However, there is a chance that complications can occur. Serious adverse events can occur including:
- cardiac arrest (heart stops beating)
- cerebrovascular accident (stroke)
- myocardial infarction (heart attack)
- paralysis or muscle weakness
- pulmonary embolism (cement leakage that migrates to the lungs)
Is the Kiva procedure covered by insurance?
The Kiva procedure is covered by Medicare and many insurance plans. Please contact your carrier to verify coverage.