GraftBolt®: ACL tibial fixation device

GraftBolt®: ACL tibial fixation device

• 13 September 2011

Introduction

The anterior cruciate ligament (ACL) helps stabilise the knee joint when changing direction. ACL injury affects 1 in 3500 people, resulting in 95,000 new ACL ruptures per year. The ACL is commonly reconstructed using the patient’s own hamstring tendons to form a quadruple graft that is secured in the tibia and femur. Approximately 60,000 – 75,000 ACL reconstructions are performed in theUSalone.

The Problem

The most common way of securing the tendon graft in the tibia is to use an interference screw, or the Intrafix^TM tibial system. However, the failure rate of ACL reconstruction is between 5% and 25% and the main cause of graft failure in the early post-operative period is loss of graft fixation within the tibia.

The Solution

A new ACL tibial fixation device was developed by Mr Martyn Snow, an Orthopaedic Registrar at University Hospital of South Manchester NHS Foundation Trust in collaboration with mechanical engineers, Dr Bin Wang and Dr Mahmoud Chizari, based at University of Manchester. The initial development work and testing was funded by a TRUSTECH Pathfinder Development

Fund Award and some funding from theUniversityofManchester.

The Process

The TRUSTECH and University funding was used to:

• refine the initial design;
• carry out some computer modeling of the performance of the device;
• perform testing of early prototypes; and
• pay for the drafting and filing of a UK patent application.

A number of companies were then approached about the device. One of the companies expressed an interest and after testing some of the device prototypes a licence agreement was drafted and negotiated by TRUSTECH. Patent protection of the innovation in a number of territories is now being progressed and the device was placed on the market in 2010.

The partnership between the NHS Trust, the University, the company and TRUSTECH that led to the development of the device was recognised with a PraxisUnico Collaborative Impact Award in June 2011, see the news story for a full review.

Where can I get one?

GraftBolt­­^® is being manufactured and sold under licence by Arthrex Inc. For more information visit the Arthrex website: www.arthrex.com.

GraftBolt Case Study 16 04 2012