For anterior cruciate ligament graft fixation
ID5: Distribute the Product
A new ACL tibial fixation device (GraftBolt®) was developed by an NHS surgeon at the University Hospital of South Manchester NHS Foundation Trust in collaboration with University of Manchester mechanical engineers. TrusTECH (NHS Innovation Hub for the North West) and the University funded the initial development work, testing and patent filing. Arthrex was granted a licence to manufacture and sell the device. GraftBolt® was placed on the market by Arthrex in 2010.
- Innovation Owner:
- Robert Chesters
- Development stage:
- ID5: Distribute the Product
The anterior cruciate ligament (ACL) in the back of the knee stabilises the knee joint. ACL injury affects 1 in 3500 people, with 80,000-250,000 ACL injuries per year worldwide. It is commonly repaired using the patient’s own hamstring tendons to form a quadruple graft that is secured in the tibia (shin bone) and femur (upper leg bone). The NHS performs around 11,000 ACL reconstructions per year, with 60,000-75,000/year in the US.ACL reconstruction is not universally successful, with failure rates of 5-25% often resulting in further surgery and long term problems. The main cause of this is loss of graft fixation within the tibia in the early post-operative period.
The GraftBolt device consists of a tapered sleeve and a screw. The sleeve has tabs on its external surface that are deployed when the screw is inserted. The tabs push the graft against the bone tunnel wall and promote fixation.
The solution provides the following benefits:
- GraftBolt aims to improve the patient’s quality of life by successfully repairing their injury first time.
- GraftBolt improves the quality of bonding the graft to the bone, which should speed up the healing of the graft implant and hence improve the patient’s rehabilitation.
- GraftBolt allows the graft strands to be separated and tensioned in a controlled manner and provides significant compression of the graft in the bone tunnel, resulting in excellent graft fixation. As a result, GraftBolt® has a higher pullout strength than the main competing product.
- Using GraftBolt should lead to fewer hospital readmissions for ACL reconstruction failure, which could lead to a cost saving to the NHS and other healthcare providers. An ACL revision operation in the NHS costs £3,000-£3,500, and sometimes two operations are required. Thus, use of GraftBolt® could save up to £6,000 per ACL reconstruction prevented.
- Clinical outcomes
- Patient experience
- Acute Care
- Trauma and Orthopaedics