Journey 2 Multi Center Kinematic Study

The University of Tennessee, Knoxville201 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

201

Conditions

Total Knee Arthroplasty

Interventions

Total Knee ArthroplastyDEVICE

Participants have previously undergone a total knee replacement surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients in the age range of 18 years to 85 years (both inclusive) 2. Patients who have a BMI less than 35 3. Patients who do not have previous surgery on the implanted knee that might restrict their movement 4. Patient who are at least 6 months post-operative 5. Patients who do not experience any pain or other post-operative complications 6. Patients who have a stable TKA and can perform a deep knee bend activity 7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms 8. Subjects will have a Journey II knee system Exclusion Criteria: 1. 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. 2. Patients who have currently enrolled in a fluoroscopic study within the past year. 3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims. 4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study. 5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability 6. Subjects who are unable to perform a deep knee bend. 7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents. 8. Subjects without the required type of knee implant.

Locations (1)

University of Tennessee

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Femorotibial Medial Condylar Rollback

The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].

Time frame: 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. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].

Time frame: Baseline, at time of observation

Femorotibial Axial Rotation

The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[deg\].

Time frame: Baseline, at time of observation

Femorotibial Weight Bearing Flexion

The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[deg\].

Time frame: Baseline, at time of observation

Data from ClinicalTrials.gov

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