Trial Status: Complete
All Ligaments Left In Knee Arthroplasty Trial
Background
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.
SUMMARY
To test the theoretical basis of this design (and support a wider introduction of Vanguard XP knee), a multi-centre clinical study in the UK was conducted to document the safety and effectiveness of the new device. To achieve this, the Vanguard XP (double cruciate retaining) was compared against an equivalent single cruciate retaining device, the Vanguard CR. The Vanguard CR was the implant of choice for these patients and fit the PICO profile for an appropriate trial comparator. The Vanguard CR is a knee replacement system with a well-documented performance and had been the device of choice in many institutions.
ALLIKAT was a multicentre randomised controlled trial that recruited patients from four centres in the UK. The study is now completed.