Comparison of TKAs Using Force Plate Analysis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.

Detailed Description
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48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies. The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.

Official Title
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Comparison of Different TKAs Using Objective Dynamic Functional Analysis

Conditions
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Knee Osteoarthritis, Total Knee Arthroplasty, Knee Injuries, Knee Arthritis

Intervention / Treatment
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* Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA
* Device: Depuy Synthes ATTUNE PCR TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents. Exclusion Criteria: Subjects who are unsuitable candidates for the two types of knee implants under investigation. Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty. Subjects with significant comorbidities that might be at an increased risk of post-operative complications. Subjects who are unwilling to sign Informed Consent/HIPAA documents. Subjects who cannot perform the required activities after the surgery.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Depuy Attune<br>Subjects will have been implanted with the Depuy Attune PCR TKA | Device: Depuy Synthes ATTUNE PCR TKA<br>* Subjects will have been implanted with the Depuy Attune PCR TKA<br>|
| Active Comparator: MicroPort Medial Pivot<br>Subjects will have been implanted with the Microport Evolution Medial Pivot TKA | Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA<br>* Subjects will have been implanted with the Microport Evolution Medial Pivot TKA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | pre-operatively | 
| Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | 6 weeks post-operatively | 
| Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | 3 months post-operatively | 
| Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | pre-operatively | 
| Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | 6 weeks post-operatively | 
| Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | 3 months post-operatively | 
| Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | pre-operatively | 
| Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | 6 weeks post-operatively | 
| Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | 3 months post-operatively | 
| Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | pre-operatively | 
| Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | 6 weeks post-operatively | 
| Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | 3 months post-operatively | 
| Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | pre-operatively | 
| Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | 6 weeks post-operatively | 
| Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | 3 months post-operatively |