SBIR Phase II: Development of an Innovative Total Knee Replacement Device Leveraging Truss Implant Technology

Period of Performance: 11/10/2014 - 10/31/2016

$750K

Phase 2 SBIR

Recipient Firm

4-Web Spine Inc.
6170 Research Rd. Suite 219
Frisco, TX 75033
Firm POC, Principal Investigator

Abstract

The broader impact/ commercial potential of this Small Business Innovation Research (SBIR) Phase II project is aimed at reducing the impact of knee arthritis and improving the quality of life for those suffering from this debilitating condition, while simultaneously strengthening the bond between academia and industry by providing students with unique research opportunities through the development of a novel Total Knee Replacement technology. Over 600,000 total knee replacement procedures are performed annually, comprising 8% of all Medicare spending. Total hospital charges for this procedure approached $40 billion for 2012. The revision rates for this procedure are significant: 10% at 10 years and 20% at 20 years. Considering the aging population of the United States, the number of total knee replacements and revisions are steadily increasing and the majority of these will be completed under Medicare coverage. The primary cause for revision surgery is loosening of the implants. This innovation aims to develop an anchoring method for implantable orthopedic devices that will reduce the total number of revision procedures performed by creating a more stable interface between the bone and the device, and therefore enhance the scientific and technological understanding of orthopedic implants in general. The proposed project is a device that utilizes structural engineering principles such as load transfer and truss design to improve osteo-incorporation of a total knee replacement implant; such a device is likely to be more efficacious than current designs. Currently available systems suffer from significant revision rates after being implanted only a short while. With younger patients receiving these implants, devices need to be developed that will give the mobility and quality of life required by these patients. The novel web structure fixing the tibial tray of a total knee replacement into the bone should provide improved initial fixation, reduce micro-motion, and eliminate aseptic loosening, all of which contribute towards a reduced revision rate and improved patient comfort. After using the information gained from the Phase I SBIR investigation to inform computational models, the design of this device will be finalized. The device will then be subjected to rigorous mechanical testing to investigate its performance in vivo, while simultaneously serving to satisfy the testing requirements mandatory for FDA approval.