A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

Study Overview
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Brief Summary
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This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the iTotal) versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Detailed Description
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This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar.

Official Title
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A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: iTotal PS Knee Replacement System
* Device: Off-the-Shelf Knee Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implant must be a minimum of 6 months post-op and doing well in the opinion of site staff Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design > 18 years of age Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations Exclusion Criteria: Simultaneous or staged bilateral procedure BMI > 40 Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function Participation in another clinical study which would confound results Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

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 |
| --- | --- |
| iTotal PS KRS<br>Patients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing. | Device: iTotal PS Knee Replacement System<br>* Total Knee Replacement systems (Patient Specific)<br>|
| Off-the-Shelf KRS<br>Patients who have had an off-the-shelf (posterior stabilized) knee replacement at least 6 months prior to testing. | Device: Off-the-Shelf Knee Replacement System<br>* Total Knee Replacement systems (Off-the-shelf)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional testing differences | Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants | At least 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Clinical Rating Score | Comparison of scores and sub-scores from the following questionnaires between the study arms | At least 6 months post-surgery | 
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Comparison of scores and sub-scores from the following questionnaires between the study arms | At least 6 months post-surgery | 

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