A team at the Hannover Medical School, Clinic for Trauma Surgery successfully used a customized, resorbable bone replacement scaffold from BellaSeno. The team was led by Prof. Dr. Philipp Mommsen, who reconstructed a 14cm segmental bone defect of the radial shaft for a third-degree open infected fracture from a traumatic gunshot injury.
 
The patient had previously undergone eleven surgeries with soft tissue and bony debridement to close the wound and the radial fracture was stabilized with a ring fixator.  After six operations the bone reconstructive surgery was performed at Hannover Medical School.
 
BellaSeno’s resorbable scaffold was used with an autologous bone graft. The scaffold is based on Evonik’s biodegradable polymer platform, Resomer. Three months after the surgery, the patient showed timely bone integration and had adequate elbow function without signs of a wound-healing disorder or clinical signs of infection. 
 
A case study was recently published in the Journal of Personalized Medicine. 
 
BellaSeno’s scaffold was designed as a customized cage to match patient anatomy for a secure hold of autologous bone graft (RIA material) in the large void. Positioning an arterio-venous loop or central vascular pedicle is used to ensure proper internal vascularization. Certain design features were included to allow for the placement of a fragile structure inside the scaffold. 
 
The scaffold was manufactured based on the ‘no-touch’ approach by BellaSeno’s AI-driven additive manufacturing facilities. 
 
The cage consists of an outer and inner support frame and a locking part that consists of bioresorbable, GMP-grade Resomer polycaprolactone (mPCL). 
 
Dr. Mommsen, Managing Senior Physician at Clinic for Trauma Surgery at Hannover Medical School and lead author of the paper said: “As the example of the 46-year-old patients demonstrates, sophisticated solutions to treat large bone defects are scarce. BellaSeno’s scaffold enabled us to conduct a new surgical technique for graft vascularization by embedding a vascular muscle arcade directly into a patient-specific, 3D-printed bioresorbable scaffold. This surgical procedure represents an innovative and promising approach for the restoration of extensive bone defects. As we see an increasing number of such catastrophic and very difficult to treat defects we are facing a rapidly growing medical need to reconstruct such injuries.”
 
“The sheer size of such defects and the lack of vascularization have limited the optimal treatment of large-volume bone defects,” said Priv. Doz. Dr. med. Tobias Grossner, CMO of BellaSeno. “Using one of our scaffolds, the outstanding team at Hannover Medical School was able to perform the reconstruction of such an extensive radial shaft bone while ensuring immediate vascularization. This demonstrates the power of our technology to improve the surgical treatment of large bone defects, individually customized to the specific anatomy of the patient and the design preferences of the surgeon.”
 
“This case study once again underlines the versatility of our technology. Almost any design request by a medical team can be fulfilled to optimize the patient’s treatment. The open structure of the scaffold enables vascularization which is crucial not only for proper bone healing but also to allow access of immune cells and anti-microbial drugs to prevent surgical site infections. We are currently working on next-generation bone scaffolds made of a composite of PCL and bio-active glass with anti-infective properties.” BellaSeno CEO, Dr. Mohit Chhaya, added. 
 
BellaSeno´s MDR-certified manufacturing platform meets the requirements of medical scaffolds ranging from soft tissue to bone and enables the production of off-the-shelf and custom-made sterile medical implants.