Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Study Overview
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Brief Summary
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Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Detailed Description
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Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.

Official Title
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Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Lower Limb Deformity, Post-traumatic Deformity, Complications, Arthroplasty

Intervention / Treatment
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* Device: Vanguard XP Bicruciate Knee System
* Device: Vanguard CR Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cemented application of components bilateral subjects randomized by knee patients with pre-existing contralateral knee surgery painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved correction of varus, valgus, or posttraumatic deformity sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament Exclusion Criteria: cementless application of components BMI greater than or equal to 40 use of Anterior Stabilized Bearings patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees correction or revision of previous joint replacement procedure on index knee infection sepsis osteomyelitis Relative exclusion criteria: uncooperative patient or patient with neurological 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 Bicruciate Knee System<br>153 patients receive Vanguard XP Bicruciate Knee System | Device: Vanguard XP Bicruciate Knee System<br>* The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.<br>|
| Active Comparator: Vanguard CR Knee System<br>153 patients receive Vanguard CR Knee System | Device: Vanguard CR Knee System<br>* The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Knees Reported as Feels Normal on a Single Assessment Numeric Evaluation (SANE) | Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Knee Society Score | The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes. | 12 months | 
| Revisions/Removals | Number of study device revisions or removals reported during the study. | 3 years | 
| Number of Knees Reported as Feels at Least 80% of Normal on a Single Assessment Numeric Evaluation (SANE) | Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function. | 12 Months | 
| Number of Knees With Which Participants Reported Being Happy or Very Happy | Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included I have never been happy, Ok - but not perfect, Happy, and Very Happy. | 12 Months |