An interventional study of Vanguard XP Bi-cruciate Retaining Knee Replacement System and Vanguard CR Single Cruciate Retaining Knee System in Primary Osteoarthritis of Knee Nos, sponsored by University of Oxford. Status unknown at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-04.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Contraindications for the device:
Relative contraindications include:
Participants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee.
Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System
Participants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS.
Procedure: Vanguard CR Single Cruciate Retaining Knee System
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 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
Radiographic Assessment
Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration
Time frame: 1 & 3 Years Post Randomisation
Plan to share: No
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University of Oxford