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Study Shows Kyphoplasty is Effective Treatmentfor Vertebral Fractures

A large, randomized long-term study of spinal augmentation showed that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral compression fractures.

The study, Fracture Reduction Evaluation trial (FREE), was conducted at 21 sites in 8 countries and randomly assigned 300 patients by a computer generated sequence to receive kyphoplasty or non-surgical care. Adults with 1 to 3 acute vertebral compression fractures (VCF) were eligible for enrollment.

“In addition to pointing out the safety and effectiveness of kyphoplasty, the study will help to improve decisions regarding the use of kyphoplasty, or other treatments such as vertebroplasty, as an early treatment option,” said Stephen Burstein, MD, Director of Neurosurgery at South Nassau Communities Hospital. “The study is important to the advancement of spinal augmentation because it had well-defined primary and secondary outcomes, clear sample-size justification, long-term follow up and the presence of a control group.”

A VCF occurs when the vertebral body – the thick section of bone at the front of the vertebrae, which are the bones that make up the spine – fractures and collapses. Approximately 700,000 VCF are diagnosed per year in the U.S. Less than half of them – just 260,000 – are diagnosed due to substantial pain. Patients with painful VCFs have traditionally received palliative care, including bed rest, narcotic analgesics and external bracing. There are 150,000 hospitalizations per year for the medical management of VCFs.

In cases with multiple VCFs, the spine will shorten and angle forward, resulting in kyphosis, which is easily identifiable by a stooped or hunchbacked posture. If not treated, multiple VCFs have a compression effect on internal organs, leading to a multitude of serious complications, including:

  • Alteration in mobility
  • Decreased appetite and sleep disorders
  • Deficient pulmonary (lung) function
  • Risk of more fractures
  • Curtailed quality of life, caused by feelings of loneliness and sadness
Balloon kyphoplasty requires just two small incisions that are less than three millimeters in length. The incisions serve as portals for an endoscope and a pencil-thin tube. An endoscope is a thin, pen-shaped instrument with a very small video camera attached to the end of it that transmits a three-dimensional, magnified view of the surgical field on a high definition monitor, giving the surgeon a clear and unobstructed view ofthe damaged area.

Relying on the view on the monitor, the surgeon inserts the tube and positions it precisely in the center of the vertebral body to deploy the balloons. When the tube is set, it is used to inflate the tiny balloons, which gently push the bones back to their normal height and shape. This creates a gap (or cavity) that the surgeon fills with bone cement only after removing the inflatable bone tamp. After the cement is placed and hardens, the tubes are removed from the incisions, which require just one stitch each to close.

Approximately 95 percent of the patients to receive balloon kyphoplasty report a complete recovery. They are able to return to the daily activities of their choice. Because the bone cement hardens within 15 minutes, the healing time from the patient’s point of view is minimal. “Most patients are discharged on the same or next day, and they can go back to normal activities of daily living immediately,” said Dr. Burstein.

In addition to kyphoplasty, South Nassau’s team of neurologic and orthopedic spinal surgeons specialize in advanced minimally invasive spine surgeries that have proven to provide short- and long-term relief from debilitating, painful back problems.

These include:

  • Neurostimulation, a small implantable electrical device that generates a periodic electrical stimulation that alleviates the throbbing pain caused by chronic back pain conditions
  • Lumbar Disc Replacement, which is prescribed for patients with one diseased disc and have failed six months of non-invasive treatment, such as pain medication or a back brace
  • X STOP, a minimally invasive, ambulatory surgery to implant a device that alleviates the debilitating pain and symptoms of spinal stenosis. X STOP typically takes less than one hour and allows patients to walk out of the hospital the same day. In a two-year research study of X STOP, only 6% of patients in the study did not have a satisfactory treatment outcome.

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