Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions

Study Overview
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Brief Summary
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Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty was analyzed by the Center for Musculoskeletal Research in a past research study, and it was determined that subjects experienced more normal-like kinematic patterns. They also achieved excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the revised design to determine if subjects experience normal-like kinematic patterns and if greater weight-bearing knee flexion is achieved. The objective for this study is to analyze the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and compare those patterns to subjects having a normal knee and those having the 1st generation Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.

Official Title
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In Vivo Comparison of Knee Kinematics for Subjects Implanted With a Smith & Nephew Journey Posterior Stabilizing (PS) Total Knee Arthroplasty (TKA) and Subjects Having a Normal Knee

Conditions
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Knee Injuries

Intervention / Treatment
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* Device: Journey II BCS TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for implanted subjects: Implanted with a Journey II BCS At least 3 months post-operative with no other surgical procedures within the past 6 months Body Mass Index (BMI) < 40 Body weight < 250 lbs Not pregnant Knee Society score (KSS) of > 90 Must be able to walk on level ground without aid of any kind Must be able to perform deep knee bend activity without aid of any kind Must be able to perform chair-rise activity without aid of any kind Must be willing to sign both Informed Consent and HIPAA forms Speak English Exclusion Criteria for implanted subjects: Other surgical procedures performed within the past 6 months < 3 months post-operative Pregnant Severe cardiopulmonary or neurologic disease Body weight > 250 lbs BMI > 40 KSS < 90 Unable to perform 3 required activities unassisted Unwilling to sign both Informed Consent and HIPAA forms Prisoner Mental disease Unable to speak English Inclusion Criteria for non-implanted subjects: healthy, well-functioning knee with no osteoarthritis or knee pathologies no other surgical procedures within the past 6 months that will prohibit them from performing the three required activities Body Mass Index < 40 Body weight < 250 lbs Not pregnant Knee Society score of > 90 Must be able to walk on level ground without aid of any kind Must be able to perform deep knee bend activity without aid of any kind Must be able to perform chair-rise activity without aid of any kind Must be willing to sign both Informed Consent and HIPAA forms Speak English Exclusion Criteria for non-implanted subjects: Other surgical procedures performed within the past 6 months that would prohibit them from performing three required activities Any past knee pathologies, osteoarthritis or knee surgeries, including implants Pregnant Severe cardiopulmonary or neurologic disease Body weight > 250 lbs BMI > 40 KSS < 90 Unable to perform 3 required activities unassisted Unwilling to sign both Informed Consent and HIPAA forms Prisoner Mental disease Unable to speak English

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smith & Nephew Journey II BCS TKA<br>Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates | Device: Journey II BCS TKA<br> <br> |
| Normal knee<br>Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematics Translations During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB | 3 months post-operative | 
| Kinematics During Deep Knee Bend (DKB) Activity | Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB | 3 months post-operative | 
| Kinematics Translations During Squat to Stand (S2S) Activity | Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S | 3 months post-operative | 
| Kinematics During Squat to Stand (S2S) Activity | Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S | 3 months post-operative | 
| Kinematics Translations During Ramp up Activity | AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity | 3 months post-operative | 
| Kinematics During Ramp up Activity | AR of the femur during Ramp Up activity | 3 months post-operative | 
| Kinematics Translations During Ramp Down Activity | AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity | 3 months post-operative | 
| Kinematics During Ramp Down Activity | AR of the femur during ramp down activity | 3 months post-operative |