Journey 2 Multi Center Kinematic Study

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107414
• Other study ID #: 20203268
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2023
• Source: The University of Tennessee, Knoxville
• Contact: Michael LaCour, PhD
• Phone: (865) 974-2093
• Email: mlacour[@]utk.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Total Knee Arthroplasty
Participants have previously undergone a total knee replacement surgery.

Locations

Country	Name	City	State
United States	University of Tennessee	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femorotibial Medial Condylar Rollback	The condylar rollback of the medial condyle will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].	Baseline, at time of observation
Primary	Femorotibial Lateral Condylar Rollback	The condylar rollback of the lateral condyle will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].	Baseline, at time of observation
Primary	Femorotibial Axial Rotation	The femorotibial axial rotation will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].	Baseline, at time of observation
Primary	Femorotibial Weight Bearing Flexion	The femorotibial weight bearing flexion will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].	Baseline, at time of observation