In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

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.

Detailed Description
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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. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.

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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Knee Osteoarthritis, Total Knee Arthroplasty, Knee

Intervention / Treatment
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* Device: Journey II Bi-Cruciate Stabilized TKA
* Device: Journey II Cruciate Retaining TKA
* Device: Journey II Bi-Cruciate Retaining TKA


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, either the BCS or XR, 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

Accepts Healthy Volunteers
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No

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>Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected | Device: Journey II Bi-Cruciate Stabilized TKA<br>* Total Knee Arthroplasty System<br>|
| Journey II Cruciate Retaining<br>Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) | Device: Journey II Cruciate Retaining TKA<br>* Total Knee Arthroplasty System<br>|
| Journey II Bi-Cruciate Retaining<br>Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained | Device: Journey II Bi-Cruciate Retaining TKA<br>* Total Knee Arthroplasty System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medial AP Translations, in mm | Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. | At least 6 months postoperative | 
| Lateral AP Translations, in mm | Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. | At least 6 months postoperative | 
| Maximum Flexion, in Degrees | Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending. | At least 6 months postoperative | 
| Axial Rotation, in Degrees | Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion. | At least 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty