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

The University of Tennessee, Knoxville

Status: Completed

Conditions: Knee; Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Device: Journey II Cruciate Retaining TKA; Device: Journey II Bi-Cruciate Retaining TKA; Device: Journey II Bi-Cruciate Stabilized TKA

Study type: Observational

Funder types: Other

Identifiers

NCT04612036

WIRB20203268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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, either the BCS or XR, 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.

Trial design

60 participants in 3 patient groups

Journey II Bi-Cruciate Stabilized

Description:

Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected

Treatment:

Device: Journey II Bi-Cruciate Stabilized TKA

Journey II Cruciate Retaining

Description:

Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)

Treatment:

Device: Journey II Cruciate Retaining TKA

Journey II Bi-Cruciate Retaining

Description:

Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained

Treatment:

Device: Journey II Bi-Cruciate Retaining TKA