Primary Osteoarthritis of Knee Nos Clinical Trial
Official title:
Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.
The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is
to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate
(Vanguard XP) by comparing it with a control group of patients implanted with an established
single cruciate retaining device (Vanguard CR). The study also aims to examine short and long
term descriptive cohort outcome data. A small preference cohort group of 60 patients
receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data
will be used to confirm the external validity of the RCT group and to contribute to the
safety data for the British Orthopaedic Association's Beyond Compliance Programme.
Evaluation will include intra-operative and post-operative complications, longer term
survivorship and patient reported outcome measures.
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