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

Completed

Conditions: Knee Osteoarthritis
Knee
Total Knee Arthroplasty

Interventions: Device: Journey II Cruciate Retaining TKA
Device: Journey II Bi-Cruciate Retaining TKA
Device: Journey II Bi-Cruciate Stabilized TKA

Registration Number: NCT04612036

Lead Sponsor: The University of Tennessee, Knoxville

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Journey II Cruciate Retaining	Journey II Cruciate Retaining TKA	Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)
Journey II Bi-Cruciate Retaining	Journey II Bi-Cruciate Retaining TKA	Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained
Journey II Bi-Cruciate Stabilized	Journey II Bi-Cruciate Stabilized TKA	Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected

Primary Outcome Measures

Name	Time	Method
Lateral AP Translations, in mm	At least 6 months postoperative	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.
Medial AP Translations, in mm	At least 6 months postoperative	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.
Maximum Flexion, in Degrees	At least 6 months postoperative	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.
Axial Rotation, in Degrees	At least 6 months postoperative	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.