New Treatment Option for Spine Fractures

Osteoporosis puts 28 million Americans at an increased risk of fractures. The most common of these fractures is vertebral body compression fracture (VCF) with over 700,000 occurring each year in the United States. Debilitating vertebral body compression fractures are more than twice as common as hip fractures. Patients suffering from VCF or spine fractures typically present with a sudden onset of pain and/or localized tenderness accompanied by muscle spasm. Early diagnosis and referral are essential for fracture reduction. "Patients with vertebral compression fractures have been among the most difficult we or any physician has had to treat because the symptoms are so severe and debilitating. Until recently we have had very little to offer," commented Malcolm Shupeck, MD.

Most vertebral body fractures occur when the bones in the spine weaken and collapse. The first spine fracture changes the alignment of the spine and increases the risks of future spine fractures by 5-fold or more. As more VCFs occur, the spine shortens and falls forward, resulting in thoracic and lumbar spinal deformity. Deformity of the spine compresses the chest and abdominal cavity and can cause additional consequences such as decreased lung function, chronic, debilitating pain, sleeping disorders, compressed stomach leading to a decreased appetite, potentially resulting in malnutrition.

The conventional treatment options for spine compressions have consisted mainly of pain medications, back braces and bed rest. Medical management may not always help to mange the pain and it does not correct the spinal deformity. Conventional surgical methods are too invasive and usually outcomes are usually poor in the osteoporotic bone.

Minimally Invasive Option   The minimally invasive fracture reduction procedure is performed through a small incision made by the physician into the fractured bone. The physician then inserts a KyphXBalloon that is inflated, which moves the collapse portion of the vertebra creating a cavity. The purpose of the inflated balloon is to restore the fractured bone to its original shape. Once the balloon is deflated and removed, the surgeon can fill the cavity or void that was created with bone void filler.

Facts/Content About Balloon Kyphoplasty

Vertebral compression fractures (VCFs) have traditionally been treated with bed rest, medication and bracing, all of which attempt to decrease a patient’s pain. However, this method of treatment places the patient at high risk for the following problems:

Balloon Kyphoplasty is an excellent option associated with a low complication rate for patients suffering from painful VCFs due to primary and secondary osteoporosis, and cancer. By achieving fracture stabilization and correction of spinal deformity, patients experience significant reduction in pain and improvement in mobility, thus reducing the number of days in bed and increasing overall quality of life
 

	Step 1: Balloon insertion Through a 1-cm incision, a working cannula is placed through the pedicle, and an orthopaedic balloon is guided into the fractured vertebral body.
	Step 2: Full inflation The balloon is inflated, reducing the fracture and elevating the superior endplate. In an attempt to achieve an "en massee" fracture reduction, the approach is bilateral, using two balloons.
	Step 3: Void within vertebral body Once the fracture has been reduced, the balloons are deflated and removed. Inflation and deflation of the balloons creates a void, which serves as a repository for the bone cement. The void is then filled with KyphX® HV-R™ Bone Cement under low, manual pressure.
	Step 4: Cement fill The procedure typically takes less than one hour per fracture treated and may require a brief hospital stay. After the procedure, the patient should return to the osteoporosis-treating physician for medical management and follow-up.