Development of Anti-Cutout Implants for Internal Fixation of Osteoporotic Femoral and Humeral Neck Fractures

Professor Leung, Frankie Ka Li   (Project Coordinator (PC))

Professor Lu William Weijia   (Co-Investigator)

Mr Sloan Kulper   (Co-Investigator)

Dr Fang Christian Xinshuo   (Co-Investigator)

18

2016-03-01

1966569

Development of Anti-Cutout Implants for Internal Fixation of Osteoporotic Femoral and Humeral Neck Fractures

Anti-Cutout Implants, Humeral Neck Fractures, Internal Fixation of Osteoporotic Femoral

Others - Medicine, Dentistry and Health

ITS/171/15FP

Innovation and Technology Support Programme (Tier 2)

2015

Completed

This project aims to bring a promising new biotechnology, anti-cutout osteoporotic fracture implants, to the initial stage of commercialization. This technology addresses the global rise in rates of osteoporotic fractures and implants ""cutout"" complications (penetration into nearby soft tissue and joints like the hip or shoulder). We aim to: complete safety testing for regulatory approval (FDA/CE), and to prove manufacturing feasibility by overcoming the technical challenge of producing a small batch of clinic-ready implants. Based on consultation with industry experts, we believe this is achievable within 18 months. To streamline development, we selected a relatively simple first product: anti-cutout bone screws for humeral and femoral fractures. During testing we will compare the safety and effectiveness of our anti-cutout screw with existing screws via in vitro biomechanical experiments on cadaveric and artificial bone, and in vivo biocompatibility experiments on rabbit models, based on established FDA/CE protocols. Next, we will develop the prototype screw into a design ready for clinical use based on FDA design controls and manufacturing standards. We strongly believe that this project has a high likelihood of success, bringing health benefits to millions of patients worldwide and help to build Hong Kong’s reputation as a medical device innovation hub.