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a new treatment for osteoporotic fractures

Background and history
The traditional treatment for fractures of the spine caused by osteoporosis has included pain reduction (medication), bed rest and bracing. In 1984, a surgical technique designed to reduce the pain and loss of function called "Percutaneous Vertebroplasty" was developed in France. In 1998, the Food and Drug Administration approved a special balloon, the KyphX Inflatable Bone Tamp, for use in reducing (setting) fragility fractures to help them heal and creating a cavity in the soft inner bone in the vertebral body.

Approximately 500 patients have undergone the new procedure in the United States since the balloon’s approval. The procedure is currently undergoing studies comparing it to other treatments.

What is an osteoporotic fracture?
 In this type of fracture, the top of the vertebral body collapses down with more collapse in front thus producing the "wedged" vertebrae, the "dowagers" hump and shortened height.

The resulting change in height and spinal alignment can lead to serious health problems, including:

  • Chronic or severe pain
  • Limited function and reduced mobility
  • Loss of independence in daily activities
  • Decreased lung capacity
  • Difficulty sleeping

Kyphoplasty compared with vertebroplasty
Vertebroplasty and kyphoplasty are both minimally invasive surgical procedures for treating osteoporotic fractures where a cement-like material is injected directly into the fractured bone. This stabilizes the fracture and provides immediate pain relief in many cases.

Kyphoplasty includes an additional step. Prior to injecting the cement-like material, a special balloon is inserted and gently inflated inside the fractured vertebrae. The goal of this step is to restore height to the bone thus reducing deformity of the spine. Most patients return to their normal daily activities after either procedure.

Description of kyphoplasty surgery

The goals of this surgical procedure are designed to stop the pain caused by the bone fracture, to stabilize the bone, and to restore some or all of the lost vertebral body height due to the compression fracture.

  • A small incision is made in the back through which the doctor places a narrow tube. Using fluoroscopy to guide it to the correct position, the tube creates a path through the back into the fractured area through the pedicle of the involved vertebrae.

     
  • Using X-ray images, the doctor inserts a special balloon through the tube and into the vertebrae, then gently and carefully inflates it. As the balloon inflates, it elevates the fracture, returning the pieces to a more normal position. It also compacts the soft inner bone to create a cavity inside the vertebrae.

     
  • The balloon is removed and the doctor uses specially designed instruments under low pressure to fill the cavity with a cement-like material called polymethylmethacrylate (PMMA). After being injected, the pasty material hardens quickly, stabilizing the bone.

Kyphoplasty is performed at a hospital under local or general anesthesia. Other logistics for a typical procedure are:

  • The procedure takes about one hour for each vertebrae involved
  • Patients will be observed closely in the recovery room immediately following the procedure
  • Patients may spend one day in the hospital
  • Patients should not drive until they are given approval by their doctor. If they are released the day of the surgery, they will need to arrange for transportation home from the hospital

Recovery
Pain relief will be immediate for some patients. In others, elimination or reduction of pain is reported within two days. At home, patients can return to their normal daily activities, although strenuous exertion, such as heavy lifting, should be avoided for at least six weeks.

Patients should see their physician to begin or review their treatment plan for osteoporosis, including medications to prevent further bone loss.

Candidates for kyphoplasty
Kyphoplasty cannot correct an established deformity of the spine, and certain patients with osteoporosis are not candidates for this treatment. Patients experiencing painful symptoms or spinal deformities from recent osteoporotic compression fractures are likely candidates for kyphoplasty. The procedure should be completed within 8 weeks of when the fracture occurs for the highest probability of restoring height.

Risks and complications
Some general surgical risks apply to kyphoplasty, including a reaction to anesthesia and infection. Other risks that are specific to this procedure and vertebroplasty include:

  • Nerve damage or a spinal cord injury from malpositioned instruments placed in the back
  • Nerve injury or spinal cord compression from leaking of the PMMA into veins or epidural space
  • Allergic reaction to the solution used to see the balloon on the x-ray image as it inflates

It is not known whether kyphoplasty or vertebroplasty will increase the number of fractures at adjacent levels of the spine. Bench studies on treated bone have shown that inserting PMMA does not change the stiffness of the bone, but human studies have not been done. Osteoporosis is a chronic, progressive disease. As stated earlier, patients who have sustained these fractures are at an increased risk for additional fractures due to the loss of bone strength caused by the disease.