Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Study Overview
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Brief Summary
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This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.

Detailed Description
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This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study. The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.

Official Title
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Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

Intervention / Treatment
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* Device: Vanguard CR
* Device: AGC knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-op knee score of <70 Scheduled to undergo primary total knee replacement with any of the following indication: pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis. One or more compartments involved. Need to obtain pain relief and improve function Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations A good nutritional state of the patient Full skeletal maturity of the patient, patients who are at least 18 years of age. Patients of either sex Consent form read, understood, and signed by patient Exclusion Criteria: Pre-op knee score greater than or equal to 70 Infection Osteomyelitis Previous partial or total prosthetic knee replacement on the operative side Skeletal immaturity of the patient, patients who are less than 18 years of age. Sepsis Uncooperative patient or patient with neurological disorders who are incapable of following directions Osteomalacia Distant foci of infections Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb Incomplete or deficient soft tissue surrounding the knee

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
Interventional Model Description: Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AGC knee<br>Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products. | Device: AGC knee<br>* The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.<br>|
| Experimental: Vanguard CR<br>Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics. | Device: Vanguard CR<br>* The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Knee Score | Objective scoring system to rate the knee and patient's functional abilities before and after TKA | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient success | Defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of >3mm or >3 degrees | 2 year | 
| American Knee Society Score, Oxford Knee-12, SF-12 | Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires | 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y | 
| Radiographic evaluation | Assessment of patient x-rays | 6m,1y, 2y, 3y, 5y, 10y | 
| Adverse Events | Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. | any | 
| Survivorship | Implant survivorship based on removal of a study device. | 10 years | 
| Noble & Weiss Knee Score, Kujala Score | Scoring systems based on patient questionnaires | 6w, 6m, 1y, 2y |