All Ligaments Left In Knee Arthroplasty Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-center Clinical Study of Vanguard XP Bicruciate Knee System

Conditions
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Primary Osteoarthritis of Knee Nos

Intervention / Treatment
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* Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System
* Procedure: Vanguard CR Single Cruciate Retaining Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Osteoarthritis of the knee involving one or more compartments of the joint. Intact Anterior and Posterior Cruciate Ligaments. Intact collateral ligaments. Correctable coronal deformity. No more than 15 degrees of fixed flexion deformity. Exclusion Criteria: Age under 18 years. Revision knee replacement surgery. Rheumatoid Arthritis. Traumatic aetiology. History or clinical signs of ACL rupture. Previous arthroscopy related to ACL injury or reconstruction. Correction of a flexion contracture that may require extensive resection of distal femur. Altered pain perception and / or neurologic affection (for example as a complication arising from diabetes). Unable to consent for themselves. Patients with language or cognitive issues that may prevent them completing the follow up requirements. Contraindications for the device: Cementless application of components. BMI ≥40 kg/m2. Use of Anterior Stabilized Bearings. Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees. Correction or revision of previous joint replacement procedure on index knee. Infection. Sepsis.Osteomyelitis. Osteoporosis (requiring treatment). Relative contraindications include: Unco-operative patient or patient with neurologic disorders who is incapable of following directions. Osteoporosis. Metabolic disorders which may impair bone formation. Osteomalacia. Distant foci of infections which may spread to the implant site. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram. Vascular insufficiency, muscular atrophy, neuromuscular disease. Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vanguard XP Knee Replacement Surgery<br>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<br>* Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.<br>|
| Active Comparator: Vanguard CR Knee Replacement Surgery<br>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<br>* Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ) | Patient Reported Outcome Score - disease specific | 3 years post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-3L | Quality of Life Patient Reported Outcome Score | Post-operation (within 6 weeks); 1 & 3 years post randomisation | 
| Forgotten Joint Score | Patient Reported Outcome Score - disease specific | Post operation (within 6 weeks), 1, 2 & 3 years post randomisation | 
| American Knee Society Score | Functional Assessment of the knee | Post operation (within 6 weeks), 1, 2 & 3 years post randomisation | 
| Complications | Adverse events and complications related to the knee surgery | Post operation (within 6 weeks), 1 & 3 years post randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Knee, Bicruciate retaining, Vanguard XP, Vanguard CR, Surgery, Zimmer Biomet, Joint Replacement, Osteoarthritis