ALLIKAT is one of SITU’s first industry collaborative trials. ZimmerBioMet (formerly just BioMet) have funded a study as part of their Beyond Compliance portfolio. The study is lead locally by Professor David Beard and Andrew Price and is managed by Mrs Cushla Cooper. NOC surgeons Mr Will Jackson and Mr Nick Bottomley are also involved.
Zimmer-BioMet has developed a knee implant that may help a younger active patient population achieve better outcomes post-surgery. The Vanguard XP system preserves the soft tissue and all ligaments in the knee joint, enhancing autonomous repair and function. The system requires a functional Anterior Cruciate Ligament (ACL) and is constrained by the natural soft tissue in the joint. To test the theoretical basis of this design (and support the NHS remit of fully evaluating innovative implantable devices before wider use), a multi-centre clinical study in the UK is required to document the safety and effectiveness of the new device. To achieve this the Vanguard XP (double cruciate retaining) will be compared against an equivalent single cruciate retaining device, the Vanguard CR. The Vanguard CR is the current implant of choice for these patients and fits the PICO profile for an appropriate trial comparator. The Vanguard CR is a knee replacement system with a well documented performance and has been the device of choice in many institutions.
ALLIKAT is a multicentre randomised controlled trial recruiting patients from 6 centres in the UK. A non-randomised cohort study has also been incorporated to obtain longer-term follow up data.
This is the first industry collaboration for the orthopaedic team in SITU and we hope the success of this project will encourage more collaboration in the future.