Osteoporosis sufferer Virginia Klucikowski, an 87-year-old retired school nurse from Evergreen Park, Ill., and cancer patient David Sepulveda, a 65-year-old worker for the Chicago Transit Authority, are among those who annually suffer an estimated 1.4 million spinal fractures worldwide. They are also among 700,000 who have benefited from a minimally invasive procedure for treatment of spinal fractures.
This procedure known as Kyphon(R) Balloon Kyphoplasty has been shown in two recent studies to provide better back pain relief, quality of life and back function than non-surgical treatment of painful spinal fractures caused by osteoporosis and cancer.
The Cancer Patient Fracture Evaluation study showed that cancer patients who were treated with Kyphon Balloon Kyphoplasty had clinically and statistically significant improvement in back-specific function, back pain, and quality of life one month after treatment compared with those who obtained non-surgical care. The Fracture Reduction Evaluation study showed that those patients treated with Kyphon Balloon Kyphoplasty experienced statistically significant improvement in back pain, quality of life and mobility, and had greater satisfaction with their treatment on average over two years compared with patients receiving non-surgical care. Neither Klucikowski nor Sepulveda was a subject in either study.
Both Klucikowski and Sepulveda were treated by Dr. John O'Toole, a professor of neurosurgery at Rush University Medical Center in Chicago.
Regarding balloon kyphoplasty, O'Toole says, "The benefits can be near immediate pain relief of the fracture and the ability to get the patient back to a high level of function faster than typical non-operative courses of treatment."
During this procedure, a needle and tube are used to create a small pathway into the fractured bone, generally on both sides of the vertebral body. Orthopedic balloons are inserted inside the fractured bone in an attempt to return it to its correct position. Inflation creates cavities in the vertebral body that are filled with bone cement, forming an "internal cast."
Klucikowski's back pain started in January 2010 when she fell while walking her friend's dog. "All of the sudden I was flying up in the air, and then I came down hard on my fanny," she says. "I felt my organs inside of my body go up and down."
By the time Klucikowski saw O'Toole, it had been a few weeks since her fall and her back pain was severe. Lying down in bed she was fine, but any movement led to muscle spasms all throughout her back.
Klucikowski was active prior to her fall and since she was experiencing such centralized pain at her back fracture location, O'Toole says he felt that Kyphon Balloon Kyphoplasty would potentially bring about back pain relief and get her back to her high levels of activity. Klucikowski was treated as an outpatient with general anesthesia, and she was able to go home that evening. Kyphon Balloon Kyphoplasty can be performed with local or general anesthesia and on an in-patient or out-patient basis based on medical necessity depending on what the physician feels is best for the patient.
"She did very well and had almost immediate improvement in her fracture-related pain. Within a week, she was off all of her pain medications and was up and around and active," O'Toole says.
The complication rate with Kyphon Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement leakage), including serious complications, and though rare, some of which may be fatal. This procedure is not for everyone. A prescription is required. Results may vary. Keep in mind that all procedure and outcome results are specific to the individual patient. Patients should consult their physician for a complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information. It is important that patients discuss the potential risks, complications, and benefits of this procedure with their doctor prior to receiving the procedure, and that patients rely on their physician's judgment. Only a doctor can determine whether a patient is a suitable candidate for this procedure.
Unlike Klucikowski, Sepulveda didn't know what was causing the back pain that he felt for about a year. Then he was diagnosed in May 2010 with multiple myeloma, a cancer of the plasma cells in bone marrow that decreases the bone strength.
In June 2010, Sepulveda's oncologist sent him to O'Toole, who diagnosed a spinal fracture, but due to extensive bone breakdown at his spine fracture, he was not initially a candidate for balloon kyphoplasty. In August, after undergoing systemic therapy and radiation, Sepulveda was still experiencing back pain. The treatments had allowed the bone to reconstitute enough so that O'Toole could move forward with the procedure. Sepulveda was treated as an inpatient and received general anesthesia.
"Kyphoplasty offered him a chance at pain relief without undergoing a major reconstructive procedure, which obviously could be complicated in a cancer patient undergoing cancer therapy with poor bone quality," says O'Toole.
Sepulveda has recovered well after the procedure and as of 2011 is able to walk around and sleep comfortably.
O'Toole is a consultant for Medtronic, creator of Kyphon Balloon Kyphoplasty.
Kyphon(R) Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.