Journey 2 Multi Center Kinematic Study

Study Overview
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Brief Summary
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The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.

Official Title
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Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the age range of 18 years to 85 years (both inclusive) Patients who have a BMI less than 35 Patients who do not have previous surgery on the implanted knee that might restrict their movement Patient who are at least 6 months post-operative Patients who do not experience any pain or other post-operative complications Patients who have a stable TKA and can perform a deep knee bend activity Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms Subjects will have a Journey II knee system Exclusion Criteria: Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. Patients who have currently enrolled in a fluoroscopic study within the past year. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability Subjects who are unable to perform a deep knee bend. Subjects who are unwilling to sign Informed Consent/ HIPAA documents. Subjects without the required type of knee implant.

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Journey II Bi-Cruciate Stabilized<br>Participants who have been implanted with a Smith & Nephew Journey II BCS TKA | Procedure: Total Knee Arthroplasty<br>* Participants have previously undergone a total knee replacement surgery.<br>* Other names: Smith & Nephew Journey II TKA;|
| Journey II Cruciate Retaining<br>Participants who have been implanted with a Smith & Nephew Journey II CR TKA | Procedure: Total Knee Arthroplasty<br>* Participants have previously undergone a total knee replacement surgery.<br>* Other names: Smith & Nephew Journey II TKA;|
| Journey II Bi-Cruciate Retaining<br>Participants who have been implanted with a Smith & Nephew Journey II BCR TKA | Procedure: Total Knee Arthroplasty<br>* Participants have previously undergone a total knee replacement surgery.<br>* Other names: Smith & Nephew Journey II TKA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femorotibial Medial Condylar Rollback | The condylar rollback of the medial condyle will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. | Baseline, at time of observation | 
| Femorotibial Lateral Condylar Rollback | The condylar rollback of the lateral condyle will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. | Baseline, at time of observation | 
| Femorotibial Axial Rotation | The femorotibial axial rotation will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. | Baseline, at time of observation | 
| Femorotibial Weight Bearing Flexion | The femorotibial weight bearing flexion will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. | Baseline, at time of observation |