Despite Evidence of Success, Low Percentage Receiving Procedure
According to a new analysis of five clinical studies published within the past six years, there is consistent evidence that patients who are surgically treated for vertebral compression fractures (VCFs) have a lower mortality rate than patients not surgically treated. Yet despite the evidence, only a small percentage of patients receive surgical treatment.
Additionally, according to a Mid-South physician who surgically treats patients with osteoporosis and other conditions that can cause VCFs, surgically treated patients have a significant decrease in pain, improved quality of life and are less likely to be readmitted to the hospital in some cases.
All five clinical studies, which were published in various peer-reviewed medical journals, evaluated the mortality rates in patients with spinal fractures who were treated with the balloon kyphoplasty procedure and patients who received other surgical and nonsurgical treatments.
"When a patient has a spinal fracture, it can be physically limiting," said Henry Dalsania, MD, an interventional radiologist with Vascular Interventional Physicians. "A patient's mobility is decreased because they are in pain. Usually spinal fractures occur in elderly patients who may have other issues, such as diabetes or high blood pressure. This can increase the chances of morbidity if the patient isn't mobile. The balloon kyphoplasty procedure decreases the patient's pain level and improves their quality of life."
Balloon kyphoplasty is a minimally invasive procedure that repairs spinal fractures caused by osteoporosis or cancer with orthopedic balloons, which are used to gently elevate the fractured vertebra in an attempt to return it to the correct position. With the aid of a fluoroscopy machine, a physician inflates the balloon into the fractured vertebra to create a cavity, removes the balloon and injects acrylic bone cement, which hardens and stabilizes the bone.
Dr. Dalsania, who has performed the procedure for the past two years, said the procedure is done on an outpatient basis and takes about 60 to 90 minutes to complete.
Kevin Ong, PhD
Kevin Ong, PhD, a principal engineer for Exponent, an engineering and scientific consulting firm based in Philadelphia, analyzed the clinical studies and co-authored two of them. All of the studies evaluated a sample of at least 1,000 patients surgically and nonsurgically treated and followed their progress for at least 12 months.
Additionally, all surgically treated patients underwent either a balloon kyphoplasty procedure or a vertebroplasty, which is a similar procedure, but an orthopedic balloon is not used to lift the fractured vertebra.
"What is unique is that not many clinical studies have looked into the mortality rate of surgically treated patients with VCFs," Ong said. "I was surprised to find that the mortality rate in some cases was significantly lower when a patient was surgically treated. This is the first analysis of this kind."
One clinical study, which looked at 3,600 patients with VCFs caused by osteoporosis, showed that surgically treated patients had a 43 percent lower mortality rate than nonsurgically treated patients over a five-year period.
Also, another clinical study, which Ong co-authored, looked at over 1 million VCF patients and showed that patients who received the balloon kypholplasty procedure experienced an additional four-year survival benefit with fewer morbidities overall than patients who received a vertebroplasty.
"Our hypothesis is that patients who receive a balloon kyphoplasty have better height restoration, therefore the outcomes are better," Ong said. "When a patient experiences a VCF, the vertebra collapses on itself. A balloon kyphoplasty procedure corrects the curvature of the spine better than a vertebroplasty."
In spite of the collective evidence that surgically treated patients with VCFs lived longer, only a small percentage of VCF patients in the studies were treated surgically.
"Only one-fifth of the patients in the studies received a balloon kyphoplasty despite the lower mortality rate," Ong said. "Based on this evidence, I'm surprised that the procedure isn't more common."
Dr. Dalsania said the balloon kyphoplasty procedure isn't more common for a variety of reasons.
"It has been the standard treatment for a long time for a patient to use a back brace in combination with pain medication to treat a VCF and is considered to be a more conservative approach traditionally," he said.
According to Dr. Dalsania, sometimes a physician may not be aware the procedure exists.
"Typically, it's ER physicians or hospital generalists who recommend the procedure and know the treatment options because they see patients with VCFs frequently," he said. "It's important to educate all physicians that the procedure exists and improves a patient's quality of life. It's an evolving process to get the patient to the right physician, but we are moving in the right direction. "
Also, Dr. Dalsania said the stigma of a surgical procedure can seem daunting to a patient.
"It's a common misconception," he said. "There is only a small incision and minimal recovery for patients who undergo a balloon kyphoplasty. A patient goes home the same day and notices a reduced amount of pain immediately."
Additionally, Dr. Dalsania said patients have higher chances of being discharged faster and are less likely to be readmitted to the hospital.
One of the clinical studies in Ong's analysis supports this claim.
One study looked at more than 68,000 patients with VCFs and noted that patients who were nonsurgically treated were hospitalized longer than patients who received a balloon kyphoplasty or vertebroplasty. Readmission rates were 35.2 percent for patients who received a balloon kyphoplasty and 61.9 percent for nonsurgically treated patients.
Despite the evidence that only a small portion of VCF patients receive surgical treatment, Allied Market Research, a global market research firm, forecast last month that the market for vertebral compression fracture devices is expected to grow from $748 million to $1,109,000 by 2022.
Those wanting more information regarding the five clinical studies click here.