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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
260
Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.
Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, United Kingdom
RECRUITINGThe Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, United Kingdom
RECRUITINGNorth Bristol NHS Trust
Bristol, United Kingdom
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
Patient Reported Outcome Score - disease specific
Time frame: 3 years post randomisation
EQ-5D-3L
Quality of Life Patient Reported Outcome Score
Time frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation
Forgotten Joint Score
Patient Reported Outcome Score - disease specific
Time frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
American Knee Society Score
Functional Assessment of the knee
Time frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Complications
Adverse events and complications related to the knee surgery
Time frame: Post operation (within 6 weeks), 1 & 3 years post randomisation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Frimley Health NHS Foundation Trust
Frimley, United Kingdom
RECRUITING