A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Study Overview
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Brief Summary
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This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

Detailed Description
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If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

Official Title
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A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: iTotal G2 CR Knee Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical condition included in the approved Indications For Use for the iTotal® CR Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment. Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits > 18 years of age Exclusion Criteria: Simultaneous bilateral procedure required BMI > 40 Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years Poorly Controlled diabetes Neuromuscular conditions which prevent patient from participating in study activities Active local or systemic infection Immunocompromised Fibromyalgia or other general body pain related condition Rheumatoid arthritis or other forms of inflammatory joint disease Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified Diagnosed with or receiving treatment for Osteoporosis Other physical disability affecting the hips, spine, or contralateral knee. Severe instability due to advanced loss of osteochondral structure Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO) Compromised PCL or collateral ligament Severe fixed valgus or varus deformity of >15º Extensor lag > 15 º Fixed flexion contracture ≥ 15 º Unwilling or unable to comply with study requirements Participation in another clinical study which would confound results Allergy to any of the implant materials

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

| Intervention/Treatment |
| --- |
|Device: iTotal G2 CR Knee Replacement System|Total Knee replacement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2011 Knee Society Score |  | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee replacement, patient-specific