Computer-assisted Total Knee Arthroplasty (TKA) With Zimmer LPS Flex Knee System

Study Overview
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Brief Summary
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To determine clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. This study will provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.

Detailed Description
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The objective of this study is to determine the clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. Pre and post-operative clinical and gait variables will be compared within the computer-assisted group. These same comparisons will also be made between the computer-assisted surgical group and a conventional surgical group who receive the same knee implant. This study will further provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.

Official Title
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An Investigation of Total Knee Arthroplasty Kinematics on Patient Performance - The Zimmer Legacy® LPS Flex Knee System

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Procedure: Computer assist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 50-80 undergoing primary total knee arthroplasty femoral tibial varus < 7 degrees no previous joint infections anteriorcruciate ligament intact clinically significant patellofemoral or osteoarthritic degeneration Exclusion Criteria: active articular infections significant concurrent ipsilateral hip osteoarthritis chronic pain syndrome requiring medications for control history of chemical addiction significant spinal stenosis, chronic back pain, sciatica patients who are unlikely to comply with, participate in or return for follow-up visits as described in the protocol osteomyelitis, septicemia or other infections that may spread to other areas of the body highly communicable diseases, immuno-compromising conditions and/or that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease) diabetic neuropathy skeletal immaturity decreased mental comprehension and literacy pregnancy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Using the same knee implant with a conventional surgical technique. | |
| Active Comparator: 2<br>Using the same knee implant using a computer-assist surgery group is the comparator | Procedure: Computer assist<br>* same implant using a computer-assisted surgical technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles) |  | pre-op and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee pain, stiffness and function |  | preop- 1 and 2 years |