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

Knee Osteoarthritis 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: Completed

Administrative data

• NCT number: NCT04612036
• Other study ID #: WIRB20203268
• Status: Completed
• Start date: October 22, 2020
• Est. completion date: May 16, 2022

Study information

• Verified date: February 2023
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• 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, 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.

Related Conditions & MeSH terms

• Knee
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Device:
• Journey II Bi-Cruciate Stabilized TKA
Total Knee Arthroplasty System
• Journey II Cruciate Retaining TKA
Total Knee Arthroplasty System
• Journey II Bi-Cruciate Retaining TKA
Total Knee Arthroplasty System

Locations

Country	Name	City	State
United States	The 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	Medial AP Translations, in mm	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.	At least 6 months postoperative
Primary	Lateral AP Translations, in mm	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.	At least 6 months postoperative
Primary	Maximum Flexion, in Degrees	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.	At least 6 months postoperative
Primary	Axial Rotation, in Degrees	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.	At least 6 months postoperative