Journey 2 Multi Center Kinematic Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: Total Knee Arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Michael LaCour, PhD; Phone Number: (865) 974-2093; Email: mlacour@utk.edu
• Study Contact Backup: Name: Richard Komistek, PhD; Email: rkomiste@utk.edu

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Recruiting
      • University of Tennessee
      • Contact: Michael LaCour, PhD; Phone Number: 865-974-2093; Email: mlacour@utk.edu
      • Principal Investigator: Michael LaCour, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All participants will be selected by their respective surgeons. Participants will be screened by eligible surgeon staff and will have the required implant for each site.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Journey II Bi-Cruciate Stabilized; Participants who have been implanted with a Smith & Nephew Journey II BCS TKA	Procedure: Total Knee Arthroplasty; Participants have previously undergone a total knee replacement surgery.; Other Names: Smith & Nephew Journey II TKA
Journey II Cruciate Retaining; Participants who have been implanted with a Smith & Nephew Journey II CR TKA	Procedure: Total Knee Arthroplasty; Participants have previously undergone a total knee replacement surgery.; Other Names: Smith & Nephew Journey II TKA
Journey II Bi-Cruciate Retaining; Participants who have been implanted with a Smith & Nephew Journey II BCR TKA	Procedure: Total Knee Arthroplasty; Participants have previously undergone a total knee replacement surgery.; Other Names: Smith & Nephew Journey II TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20203268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes