Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

Study Overview
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Brief Summary
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This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.

Detailed Description
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This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed bearing knee). This trial will be conducted as the randomised, controlled study. Implant loosening and polyethylene wear in fixed-bearing knee prostheses were recognized as major causes of late failure. The mobile bearing knee have the theoretical advantages of potentially minimizing the polyethylene wear and reducing implant to bone interface stress in order to reduce the incidence of implant loosening. Therefore, the aims of this study are to prove the Vanguard deep dish rotating platform knee is at least as effective in clinical outcome as the widely used current design of knee replacement and better in long term survivorship. The efficacy of the device will be determined by the relief of pain, restoration of function and range of motion. The durability of device will be determined by the absence of revision/removal and radiological integrity. To assess the safety of the device, all post operative complications will be recorded either device related or otherwise. Patient satisfaction as determined by answers to patient outcome questionnaires (Oxford Knee Score, WOMAC and Lower Extremity Activity Scale).

Official Title
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Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Vanguard™ Deep Dish Rotating Platform Knee
* Device: Vanguard™ Cruciate Retaining Knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a pre-operative knee score of < 70 Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are 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: Absolute contraindications include the following diagnoses: Patients with a pre-operative knee score of >= 70 Infection Osteomyelitis Previous partial or total prosthetic knee replacement on the operative side Patients who are less than 18 years of age Sepsis Patients who had body mass index >= 40 Relative contraindications include the following factors: Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis 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, or neuromuscular disease in the 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VG DDRP<br>This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee. | Device: Vanguard™ Deep Dish Rotating Platform Knee<br>* Vanguard™ Deep Dish Rotating Platform Knee<br>|
| Active Comparator: VG CR<br>This arm utilizes the Vanguard™ Cruciate Retaining Knee. | Device: Vanguard™ Cruciate Retaining Knee<br>* Vanguard™ Cruciate Retaining Knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Score | Objective scoring system to rate the knee and patient's functional abilities before and after Total Knee Arthroplasty. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability (knee instability). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient success as defined in the Study Definition section of the protocol | Patient Success - defined by the following requirements at two-year follow-up after surgery: A Knee Score of greater than or equal to 80, and No component revisions or removals (femoral, bearing, tibial or patella), and No pending component revisions or removals (femoral, bearing, tibial or patella) and Absence of Osteolysis in any component (femoral, bearing, tibial or patella) and No migration / subsidence of >3mm or >3º in any component (femoral, bearing, tibial or patella) | 2 years | 
| American Knee Society Score | Objective scoring system to rate the knee and patient's functional abilities before and after Total Knee Arthroplasty. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability (knee instability). | 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years | 
| Radiographic Evaluation | Assessment of patient x-rays | 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years | 
| 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 Time | 
| Survivorship | Implant survivorship based on removal of the study device | 10 years |