Total Knee Arthroplasty: Functional and Clinical Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

Detailed Description
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The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

Official Title
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Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Zimmer
* Device: Stryker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring primary total knee replacement Patients willing and able to comply with the follow-up visits and evaluations Patients willing to sign informed consent approved by the Institutional Review Board Exclusion Criteria: Patients with inflammatory arthritis Patients with diabetic neuropathy Patients unable to ambulate without the use of an assistive device prior to surgery Patients unable to stand in single limb stance on each foot prior to surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stryker<br>Subjects will be receiving the Stryker Triathlon total knee replacement | Device: Stryker<br> <br> |
| Active Comparator: Zimmer<br>Subjects will be receiving a Zimmer NexGen total knee replacement | Device: Zimmer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement | The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length. | Baseline (Pre-Operative) to 6 weeks following total knee replacement | 
| Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement | The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length. | Baseline (Pre-Operative) to 52 weeks following total knee replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. | Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point. | Baseline and 52 weeks following total knee replacement | 
| Walking Speed at 6 Weeks Following Total Knee Replacement. | Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point. | 6 weeks following total knee replacement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Lower Quarter Y-Balance Test, Functional Outcomes, Patient Reported Outcomes