The severe pain associated with vertebral compression fracture affects between 700,000 and 1,000,000 patients every year in the United States, with an estimated direct health care cost of 10 to 20 billion dollars. Vertebral compression fractures may occur due to osteoporotic bone mineral loss, or may be a result of vertebral destruction due to aggressive benign or malignant tumor destruction of bone.
Osteoporosis is a pathologic process of bone mineral loss leading to deterioration of the architectural structure of bone. These changes may be age related (primary osteoporosis) or result from therapeutic drugs such as catabolic steroids, anticonvulsants, cancer chemotherapy, and heparin (secondary osteoporosis). Primary osteoporosis is the most common etiology of vertebral compression fracture, with more than two hundred million women worldwide having the disease. Women are affected approximately twice as often as men, with one in four women developing the disease after the age of 50. The use of corticosteroids is also an increasingly common cause of osteoporosis in patients with severe asthma, collagen vascular disease, transplant surgery, and certain types of cancer.
Before Vertebroplasty, the pain associated with compression fractures was treated conservatively with analgesics, bed rest and external bracing. Despite these measures, many patients have severe and persistent pain that lasts for weeks or months. Indeed, some individuals have such severe pain and interruption of normal activities of daily living that they require hospitalization for aggressive analgesic therapy. Conventional surgery is rarely considered an option, as the procedures are complex and carry substantial risk of failure or complication.
Deramond and Galibert, in Amiens, France, first performed a percutaneous vertebral augmentation in 1984. Their patient had severe pain from an aggressive hemangioma involving the C2 vertebra. Using fluoroscopic guidance, Dr. Deramond placed a large bore needle into the C2 vertebral body and infused polymethylmethacrylate, relieving the patient's pain completely. Soon, the indications were broadened by Desquenel to include patients treated for pain resulting from vertebral collapse secondary to both osteoporosis or malignant infiltration. Deramond and Galibert reported their first seven procedures in 1987, and called the procedure "Percutaneous Vertebroplasty."
In the early 1990's, the team of Dion, Jensen, DeNardo and Mathis at the University of Virginia performed the first Percutaneous Vertebroplasty in the United States using Deramond's paradigm. Percutaneous Vertebroplasty was initially slow to take hold, with relatively few centers performing cases through 1995. Continued work in Europe and the U.S. gradually began to attract attention at scientific meetings and in the lay press. Initial publications and presentations at peer reviewed meetings demonstrated an 80 to 90% success in providing immediate and significant pain relief. Medication requirements were substantially diminished, and physical and psychosocial well-being were restored.
As it is currently performed, Percutaneous Vertebroplasty is an outpatient procedure that is done most often under intravenous sedation rather than general anesthesia. Most patients are discharged after 2 to 3 hours, and despite some bruising or soreness at the operative site, are able to report a substantial improvement in their pain even before leaving the hospital.
Thousands of patients have already benefited from this therapy, with significant and durable pain relief. Percutaneous Vertebroplasty is fast becoming the standard of care for treatment of the pain associated with vertebral compression fractures.
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Information for Patients (FAQs):
What is Vertebroplasty?
Percutaneous Polymethylmethacrylate Vertebroplasty is a minimally invasive outpatient procedure that uses orthopedic cement to create an internal splint within fractured vertebrae. Under x-ray guidance, the physician inserts one or two needles into the fractured vertebrae through the skin of the back. A small amount of opacified cement (about ¼ ounce) is then injected into the vertebral bodies, and the needle is removed.
Who is a candidate?
The primary indication for vertebroplasty is to treat the pain associated with pathologic vertebral body fractures. The most commonly treated fractures are those related to bone loss and osteoporosis in the elderly, however vertebroplasty can also be used to treat vertebrae that are fractured due to infiltration by benign or malignant tumors, or fractures that occur in patients taking high doses of steroids such as those with lupus, scleroderma, asthma, or chronic obstructive pulmonary disease.
How would a vertebroplasty help me?
Vertebroplasty helps patients by providing almost immediate relief of pain related to vertebral compression fractures. Instead of spending weeks in bed hoping to recover from a fracture, patients can often return to normal activities within only two or three days of having a vertebroplasty performed. Increased activity can help prevent serious or fatal complications of bed rest such as pneumonia, or pulmonary embolism from blood clots in the legs. Vertebroplasty has also been shown to improve the psychosocial well-being of patients suffering from painful vertebral compression fractures.
How long does the procedure take?
Vertebroplasty takes about one half-hour to one hour to perform for each treated level. The total time spent in the x-ray room is usually about one, to one and one-half hours.
How long is the hospital stay?
We require our patients to remain in the Radiology recovery area for about three hours after vertebroplasty. The patient is then typically allowed to return home in the company of their family or a caretaker. Arrangements should be made for a driver and transportation.
Will I have immediate pain relief?
A large percentage of patients, perhaps even more than half, will report immediate relief of pain in the first few hours after the procedure. Most patients do report some local bruising and tenderness of the back for the first 48 to 72 hours after the procedure, but by the third post-operative day, 80 to 90 percent will report substantial or complete pain relief.
Should I be worried about the long-term effects of bone cement?
The acrylic cement that is used to perform vertebroplasty has been in use for approximately four decades. Polymethylmethacrylate is used extensively in orthopedic surgery for procedures such as cementing the components of hip and knee replacements to normal bone.
What is the success rate of the procedure?
The most recent studies report an 80 to 90 percent success rate in substantially or completely relieving patients' pain. In addition, there are statistically significant improvements in psychosocial wellbeing and functional disability. The complication rate has been extremely low.
Where can I go do get this procedure?
Most physicians who perform vertebroplasty are Radiologists, particularly Neuroradiologists. An increasing number of Orthopedists, Neurosurgeons and Anesthesiologists (pain management physicians) have begun to perform vertebroplasty in the last few years. Most university hospitals, and even large community hospitals, have a Radiologist who performs the procedure, however, the most experienced physicians are still typically in university practices.
Is this procedure covered by Medicare?
Vertebroplasty is now covered by Medicare in many states, and is expected to be covered nationwide by 2001.
Is this procedure covered by private insurance?
Most private insurers will cover vertebroplasty. Check with your individual carrier for details.
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Information for Medical Professionals (FAQs):
What are the indications for vertebroplasty?
Percutaneous polymethylmethacrylate vertebroplasty is indicated primarily for the relief of pain related to vertebral compression fractures. Most of the patients who have been treated thus far suffered from pathologic fractures related to osteoporosis, However, vertebroplasty is also useful for relieving pain related to vertebral collapse due to benign and malignant infiltrating vertebral lesions such as aneurysmal bone cysts, hemangioma, giant cell tumor, myeloma, or metastatic malignancy. Vertebroplasty has also been used for preoperative reinforcement of osteoporotic vertebrae prior to instrumentation, and for prophylaxis in patients with severe kyphosis.
What are the diagnostic requirements for evaluating indications?
Because of the frequency of multiple fractures in this population of patients, careful clinical and imaging correlation is required to determine the etiology and level of the patient's pain. Findings on plain radiographs and MRI, particularly MR demonstration of edema within a fractured vertebral body, should correlate with the level of tenderness upon palpation of the spinous processes. MRI STIR sequences are most useful for the depiction of edema.
Is the procedure performed in the hospital or outpatient surgery center?
The procedure is most often performed in the hospital, however vertebroplasty could be performed in an outpatient surgery center if high quality equipment were available. This would include not only satisfactory imaging devices, but also state-of-the-art monitoring equipment for conscious sedation as well as resuscitation devices.
What cement is used?
Any variety of polymethylmethacrylate cement can be used, however adequate opacification must be achieved in order to perform the procedure safely. We utilize Codman Cranioplastic mixed with Tracer's Barium to approximately a 25% barium mixture by weight.
Do you recommend a venogram for cement injection?
We no longer perform a venogram prior to cement injection. We feel that venography almost always demonstrates rapid egress into venous structures, but by mixing the cement to an appropriate thickness and by injecting in a controlled fashion, substantial filling of these veins can be avoided even without a prior venogram. A venogram can also complicate the cement injection when contrast still remains in the vertebral body simulating opacified cement.
What are the long-term effects of bone cement in the spine?
The long term of bone cement in percutaneous vertebroplasty have not been specially defined, however, polymethylmethacrylate has been used for over four decades as an orthopedic cement and the side effects have been studied. The strength of the bone cement and durability would be expected to outlast the native bone in elderly, osteoporotic patients.
What published clinical outcome studies would you recommend?
Approximately forty scientific papers have already been published on vertebroplasty and can be located via Medline. Randomized prospective studies are necessary to compare vertebroplasty to conservative treatment in a scientific fashion, however the results of published studies suggest a remarkable benefit over conservative therapy. Prospective long-term studies also need to be preformed to rule out the possibility of any long-term sequelae.
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