PRLog - Jan. 2, 2013 - WHITE PLAINS, N.Y. -- The U.S. Food & Drug Administration has cleared dozens of synthetic bone materials for use in spinal fusion surgery, but no one product has emerged as a clear winner. But these days, science is bringing us ever closer to the possibility of regenerating human tissue. One bone substitute in particular –ChronOS Bone Graft Substitute is being promoted by its manufacturer for the material’s ability to speed regeneration of bone cells and blood vessels when used in spinal fusion surgery. To find out if the ChronOS product performs as indicated, the seven spinal surgeons at Brain & Spine Surgeons of New York (BSSNY) have embarked on an independent study to see how the material performs. The study grant was awarded by the product’s manufacturer, Synthes, Inc.
Spinal fusion often requires bone grafts to fill a bone void and fuse vertebrae
“We have found bone substitute materials that are good and work well, but we are still searching for a bone substitute that works better,” explains John M. Abrahams, M.D., of BSSNY and Chief of Neurosurgery at Northern Westchester Hospital. “We continually seek ways to improve results for our spinal surgery patients, and the ChronOS Bone Graft Substitute strip is indicated to add more substance to the fusion mass, thereby helping patients heal better and faster.”
BSSNY is the only spinal surgery practice in the region to undertake this study. Dr. Abrahams explains: “By conducting a study of this product ourselves, we will be one of the first spinal practices that can assess whether the product benefits patients as indicated and improves fusion rates.”
Why Bone Graft Substitutes Are Needed
Why are substitute bone grafts important? When patients require spine surgery because of a traumatic accident, to correct severe scoliosis, or alleviate other neck and spinal problems, they often require a bone graft to fill in a bone void or to help fuse two vertebrae together to create a stiffer and straighter spinal column. Bone grafts can be harvested from the patient’s own hip or from a donor. However, an “autograft”
Using a synthetic substance sidesteps these issues, notes Dr. Abrahams, adding that, “Synthetic bone graft also holds the promise of augmenting the speed at which the bone heals after surgery.” ChronOS is made of calcium and phosphorous, two of the main ingredients in bone, and it takes from 6 to 18 months for the body’s own bone cells and blood vessels to replace the synthetic material, according to Synthes.
The benefit of electronic health records
With six neurosurgeons and one orthopedic spinal surgeon at BSSNY, the medical practice performs about approximately 10 - 20 spinal fusions a month on average. Dr. Abrahams says the study will follow patients for at least 18 months, using a newly installed electronic health records (EHR) system to track patient progress. In addition to measuring recovery time and bone growth, the surgeons will also document the presence or absence of pain and mobility.
Dr. Abrahams notes that it is unusual for a non-academic practice to engage in clinical studies, but he and his partners feel such research greatly benefits patients. “We’ll begin to see patterns as the study progresses, and we will gain insight on how effective the product is,” he explains. “We don’t have to wait until someone else publishes the results to know if it works. That is an important benefit to our patients.”
Brain & Spine Surgeons of New York (BSSNY) was founded in 1958 by the first neurosurgeon in the Hudson Valley. Today, BSSNY has seven Board-certified neurosurgeons and one Board-certified spinal orthopedic surgeon, who practice leading-edge medicine. In the group, patients find surgeons recognized as among the nation’s “Top Doctors,” as well as heads (past and present) of neurosurgical departments, who hold academic appointments at major university teaching centers. A team approach and on-site diagnostic capabilities allow BSSNY to accurately diagnose complex brain and spine conditions with the latest biomedical technology. We draw upon our outstanding education, training, experience, and skill to perform the most challenging surgeries. Patients who are not candidates for surgery are referred to BSSNY’s non-surgical medical practice, SPINE OPTIONS, which combines medical, physical therapies, and holistic treatments to relieve pain and help regain function. For more information, please visit www.bssny.com and www.spineoptions.com.