The first two United States patients have been successfully treated with an innovative medical device through a clinical trial underway at the Marshall University Joan C. Edwards School of Medicine, in collaboration with the Marshall Clinical Research Center and Cabell Huntington Hospital.
The institutions are working in conjunction with IlluminOss Medical, a commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, as part of its U.S. Lightfix clinical trial for the treatment of impending and pathologic fractures in the humerus due to metastatic carcinoma.
The surgeries were performed by Felix Cheung, M.D., associate professor and chief of the division of orthopaedic oncology at the School of Medicine. Cheung is a board-certified, fellowship-trained orthopaedic surgeon specializing in tumors of the musculoskeletal system and joint replacement surgery.
Gene DiPoto, senior vice president of research and development at IlluminOss Medical, worked closely with Cheung and his team to facilitate the successful surgeries. Assisting Cheung was Franklin D. Shuler, M.D., Ph.D., associate professor and vice chair of research in the department of orthopaedic surgery.
“We are excited for the opportunity to be the first clinical site in the U.S. to apply IlluminOss’ technology to the treatment of a patient with a complex fracture and the results have been remarkable,” said Cheung. “The patients were completely stable following the procedure and reported little to no discomfort. Having seen firsthand how effective the IlluminOss System is, I believe the benefits it provides to both the surgeon and the patient have the potential to make it a true game-changer in the way fracture repair can be approached.”
Both patients were diagnosed with metastatic cancer and had a pathologic fracture of the humerus.
The IlluminOss System has proven successful in the treatment of over a thousand patients in Europe, where it is commercially available and has been in clinical use since 2010. Benefits observed from the use of the IlluminOss product in patients include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant and the small diameter of the flexible catheter gives the surgeon greater freedom of surgical approach. In many cases it allows the patient to get back to daily activities more quickly without the hindrance of a hard cast.
“We have had tremendously successful results treating complex fractures with the IlluminOss System internationally and are excited to now begin applying it to the treatment of patients with impending and pathologic fractures in our first U.S. trial,” said Robert Rabiner, president of IlluminOss Medical. “The Joan C. Edwards School of Medicine is renowned for its commitment to providing excellence in both medical education and patient care and we are appreciative for the opportunity to work with such a well-respected team – led by Dr. Cheung – to help validate the effectiveness of our technology in the U.S.”
This clinical trial is underway at surgical centers across the country and is currently enrolling patients. For additional information, please refer to www.ClinicalTrials.gov. NCT 02338492