Journey 2 Multi Center Kinematic Study

NCT05107414 | Unknown FDA Device

• 1 other identifier: 20203268
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Journey II Bi-Cruciate Stabilized

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

Procedure: Total Knee Arthroplasty

Journey II Cruciate Retaining

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

Procedure: Total Knee Arthroplasty

Journey II Bi-Cruciate Retaining

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

Procedure: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty PROCEDURE

Participants have previously undergone a total knee replacement surgery.

Also known as: Smith & Nephew Journey II TKA

Journey II Bi-Cruciate Retaining; Journey II Bi-Cruciate Stabilized; Journey II Cruciate Retaining

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients in the age range of 18 years to 85 years (both inclusive)
• Patients who have a BMI less than 35
• Patients who do not have previous surgery on the implanted knee that might restrict their movement
• Patient who are at least 6 months post-operative
• Patients who do not experience any pain or other post-operative complications
• Patients who have a stable TKA and can perform a deep knee bend activity
• Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
• Subjects will have a Journey II knee system

You may not qualify if:

• 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.
• Patients who have currently enrolled in a fluoroscopic study within the past year.
• Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
• Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
• Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
• Subjects who are unable to perform a deep knee bend.
• Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
• Subjects without the required type of knee implant.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996, United States

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Michael LaCour, PhD

CONTACT

(865) 974-2093; mlacour@utk.edu

Richard Komistek, PhD

CONTACT

rkomiste@utk.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: May 15, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)