Journey 2 Multi Center Kinematic Study

The University of Tennessee, Knoxville

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Procedure: Total Knee Arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT05107414

20203268

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.

Enrollment: 220 estimated 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 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

220 participants in 3 patient groups

Journey II Bi-Cruciate Stabilized

Description:

Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA

Treatment:

Procedure: Total Knee Arthroplasty

Journey II Cruciate Retaining

Description:

Participants who have been implanted with a Smith \& Nephew Journey II CR TKA

Treatment:

Procedure: Total Knee Arthroplasty

Journey II Bi-Cruciate Retaining

Description:

Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA

Treatment:

Procedure: Total Knee Arthroplasty