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

February 20, 2023 updated by: The University of Tennessee, Knoxville

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

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • The University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Journey II Bi-Cruciate Stabilized
Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected
Device: Journey II Bi-Cruciate Stabilized TKA
Total Knee Arthroplasty System
Journey II Cruciate Retaining
Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)
Device: Journey II Cruciate Retaining TKA
Total Knee Arthroplasty System
Journey II Bi-Cruciate Retaining
Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained
Device: Journey II Bi-Cruciate Retaining TKA
Total Knee Arthroplasty System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medial AP Translations, in mm
Time Frame: At least 6 months postoperative
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
Lateral AP Translations, in mm
Time Frame: At least 6 months postoperative
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
Maximum Flexion, in Degrees
Time Frame: At least 6 months postoperative
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
Axial Rotation, in Degrees
Time Frame: At least 6 months postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Investigators

  • Principal Investigator: Michael LaCour, PhD, The University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2020

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIRB20203268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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