ALLIKAT (All Ligaments Left In Knee Arthroplasty Trial)
Research type
Research Study
Full title
Multi-Centre Clinical Study Comparing the Clinical and Patient Reported Outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System
IRAS ID
187578
Contact name
Heather House
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN12584521
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
Knee replacement surgery is a common treatment for osteoarthritis of the knee. There are different types of knee replacement systems, or ‘implants’, that can be used in the surgery. The research looking at modifications and design changes to these implants is limited. Research is needed to consider the changing characteristics of the patients who require knee surgery. Currently there is an increase in demand for knee replacement in a younger and more active population, who desire less limitation on their activities following knee replacement surgery. Current knee replacement designs sacrifice one of the main ligaments in the knee, called the Anterior Cruciate Ligament (ACL). By preserving natural knee structures, such as the ACL, it is thought that the knee will retain more normal function following surgery. The Vanguard CR is a commonly used knee replacement, and it sacrifices the ACL. Zimmer Biomet have developed a new knee replacement implant called the Vanguard XP which keeps all the main knee ligaments intact. This new design may benefit the younger, more active population. ALLIKAT is a research study which will evaluate the early outcomes of the Vanguard XP compared to the Vanguard CR. Patients will be followed up for 3 years, with information about complications both during and following the surgery, as well as patient reported outcomes. 200 patients will be randomised to receive either the Vanguard CR or the Vanguard XP, and they will not know which one they receive. There will also be a smaller group of 60 participants who will only receive the Vanguard XP. The data from this cohort group will contribute to safety and efficacy evaluation of the new implant. 260 patients will be recruited in total from 5-6 NHS sites around the UK. Non-identifiable data collected from the cohort group combined with the data from those randomised to the Vanguard XP will contribute to the Beyond Compliance Program which has been set up in the interest of patients, to support the safe and stepwise introduction of new or modified medical implants such as joint replacements.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0158
Date of REC Opinion
20 Apr 2016
REC opinion
Favourable Opinion