Foundation Knee Study - Retrospective

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.

Official Title
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Post-Market Study of the Foundation Knee System

Conditions
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Osteoarthritis, Post-traumatic Arthritis, Inflammatory Tissue Disorders, Arthritis Secondary to Other Diseases, Avascular Necrosis of the Femoral Condyles

Intervention / Treatment
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* Device: Foundation Knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have knee joint disease related to one or more of the following osteoarthritis post-traumatic arthritis inflammatory tissue disorders arthritis secondary to other diseases Avascular necrosis of the femoral condyles; Skeletal maturity Less than 70 on the Knee Society Score (rating score) Sufficient bone stock, as judged by radiographs, to support primary knee implant Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture Patient is likely to be available for evaluation for the duration of the study Able and willing to sign the informed consent and follow study procedures Patient is not pregnant No infection present No known materials sensitivity Exclusion Criteria: Skeletal immaturity Greater than or equal to 70 on preoperative Knee Society Score (Rating Score) Post-patellectomy Insufficient bone quality which may affect implant stability Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture. Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity) Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease) Prisoners Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity) Patient is pregnant Infection present Materials sensitivity

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Foundation Knee<br>Retrospective data collection on 510(k) approved device | Device: Foundation Knee<br>* Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use and efficacy of the Encore Foundation Knee System |  | 2 year |