November 15, 2010

Bone Glue Speeds Recovery

What a new bone cement called Kryptonite may be able to do for people recovering from open heart surgery.

Recovering from open heart surgery is difficult. The fact that the breastbone needs to be split during the procedure makes recovery that much harder and more painful. Until recently, the only option was to wire the two halves of the breastbone together and wait several weeks for them to knit.

A glue called Kryptonite™ Bone Cement appears to be a much better option.

The glue sets within 24 hours, meaning that patients quickly have a solid, stable breastbone (sternum), instead of two fractured pieces that need time to grow into each other and fuse.

Particularly important is that the glue makes it much easier for recovering patients to breathe deeply. A broken breastbone causes immense difficulties and pain when taking a deep breath or coughing.

The glue was originally developed by Doctors Research Group Inc of Connecticut for use in repairing defects of the skull. In 2009, Paul Fedak, a Canadian cardiac surgeon, began using the glue to repair the breastbone of open heart surgery patients. Use on 20 patients showed several benefits of the adhesive. The bone knit much faster, the closure was stronger and patients recovered more quickly, with less pain and need for painkillers.

The procedure does not require special training or equipment and takes only five minutes to perform. Currently, the glue is used in addition to wire; it does not replace the wire.

Particularly important is that the glue makes it much easier for recovering patients to breathe deeply. A broken breastbone causes immense difficulties and pain when taking a deep breath or coughing.

The glue is a polymer composed of calcium carbonate and naturally occurring triglycerides extracted from castor oil. It bonds specifically to bone, does not appear to be toxic and mimics natural bone in several ways, including hardness and porosity. The fact that it is porous means that during healing, bone cells can migrate into the glue and lay down new bone.

The encouraging results seen in individual patients led to the STICK clinical trial, where recovery was compared between 30 patients who received the bone cement and 25 patients who only received traditional wire closure of the breastbone.

Patients were assessed within 72 hours after surgery and then weekly afterward. Measurements included patient pain, analgesic use and maximum inspirational capacity (breath size).

Patients who received the glue reported approximately 1/3 less pain while coughing during the first 72 hours after surgery. Narcotic use was less than half that in the wire closure group. And patients who received the glue had significantly higher breathing capacity within 48-72 hours after surgery, an effect which persisted during the full six weeks that it was measured. Patients who received the bone cement also reported higher quality of life and less disability during the recovery period.

After eight months of follow-up, no associated side effects or complications have been seen in patients who received the glue.

The cement is made by mixing three separate liquids and polymerizes (solidifies) slowly. This potentially allows doctors to inject it as a liquid or to shape it into a moldable putty for use during bone grafts. If larger trials bear out the initial results, the material may prove useful in treating many different types of bone fractures and defects, not just those that occur during open heart surgery.

Currently, the bone cement has been used on over 500 patients in the U.S. and Canada.

The initial results of the STICK trial were presented during the 2010 Canadian Cardiovascular Congress, held in Montreal, October 23-27. A lengthy abstract of this presentation, which includes a graph of the respiratory capacity of recovering patients, was published in Supplement SD of the Canadian Journal of Cardiology, October 2010 and is freely available.

Paul W.M. Fedak, MD, PhD, FRCSC, is a cardiac surgeon at Foothills Medical Centre in Calgary, assistant professor in the Department of Cardiac Sciences at the University of Calgary and a Clinical Investigator of the Alberta Heritage Foundation for Medical Research.

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