Department, Unit, College Name

GEM OS1, Bone Graft Treatment

A Less-Painful Alternative

Dr. Drew Murphy, A Campbell Clinic surgeon who is a foot and ankle specialist, is currently overseeing Campbell’s participation in a clinical trial involving the use of the GEM OD™1 bone graft treatment in patients who have had foot and ankle fusion surgery.

“Many elective surgeries for correction of deformity of the ankle and foot involve fusion of one or more joints for stability and improved function,” Dr. Murphy said. “Most fusion require some type of supplementary graft to improve the success of the fusion.”

Traditional graft techniques involve harvesting bone from other sites on a patient’s body, which may result in more pain and potential complications. GEM OS1, a synthetic bone graft material developed by BioMinetic Therapeudics, can replace autogenous (from the patient) bone graft in foot and ankle fusion applications. The GEM OS1 material is placed directly into an open surgical site to stimulate bone regenerations.

Dr. Murphy has performed a number of fusion surgeries using the GEM OS1 graft. “Most situations that require bone graft are amenable to using this type of product,” he said.

Comparing Results

Campbell Clinic’s large patient base makes it a good site for recruiting participants in clinical trials. The GEM OS1 research was a nationwide study, involving numerous centers.

In the clinical trial supervised by Dr. Murphy, researchers compared two groups of patients who had undergone fusion surgery: those who had autogenous bone grafts, and surgeries in which the GEM OS1 material was used. Working with Dr. Murphy in the trial were Campbell Clinic surgeons Dr. Greer Richardson, Dr. Susan Ishikawa, and Dr. David Richardson.

The GEM OS1 study was a non-inferiority trial. Researchers were looking in whether bone regeneration following use of the GEM OS1 material was at least comparable to regeneration following autograft bone graft, without the pain and other negatives associated with the harvesting of the autograft. Assessment of bone regeneration was based on CT scans performed six months after surgery.

Mr. Murphy and his fellow researchers completed their report on the Campbell Clinic-based trial in December 2008. “The final outcome of the multi-center clinical trials in not known yet, but the initial results look promising for the ability to substitute this product for autograft,” Dr. Murphy said.