Trauma to the head, caused by gunshot or high impact motor vehicle accident, for example, can cause open fracture of the skull resulting in a cranial defect with more than cosmetic consequences – a void in the skull may leave the brain unprotected and vulnerable to further injury. Current treatment modalities for craniotomy repair include metal, plastic, or other inert synthetic materials for closure of the void. Attempts at regenerating healthy bone to correct skull defects currently requires harvesting an autologous bone graft, usually from the patient’s hip, potentiating significant complications at both the donor site and graft site. There is a clear unmet medical need for effective regenerative skull repair affecting all aspects of our nation’s civilian and military population. The proposed plan directly addresses this need by bringing a validated and highly effective bone graft technology from prototype to the patient. The goal of this project is to clinically test a new synthetic resorbable bone graft implant in skull repair. Future development involves application of the bone healing technology to orthopedic, dental, and spine indications.
To view an interview with Dr. DeCarlo discussing the cranial bone graft implant, please click the Movie link below or following Vimeo link https://vimeo.com/73633252.
To view the proposed clinical trial please click the PDF link below.