Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions

October 8, 2019 updated by: Richard Komistek, The University of Tennessee, Knoxville

In Vivo Comparison of Knee Kinematics for Subjects Implanted With a Smith & Nephew Journey Posterior Stabilizing (PS) Total Knee Arthroplasty (TKA) and Subjects Having a Normal Knee

Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty was analyzed by the Center for Musculoskeletal Research in a past research study, and it was determined that subjects experienced more normal-like kinematic patterns. They also achieved excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the revised design to determine if subjects experience normal-like kinematic patterns and if greater weight-bearing knee flexion is achieved. The objective for this study is to analyze the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and compare those patterns to subjects having a normal knee and those having the 1st generation Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

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, 37923
        • Tennessee Orthopaedic Foundation for Education and Research
      • Knoxville, Tennessee, United States, 37996
        • The University of Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Tennessee Orthopaedic Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) implanted by Dr. Harold E. Cates or subjects with a healthy knee

Description

Inclusion Criteria for implanted subjects:

  • Implanted with a Journey II BCS
  • At least 3 months post-operative with no other surgical procedures within the past 6 months
  • Body Mass Index (BMI) < 40
  • Body weight < 250 lbs
  • Not pregnant
  • Knee Society score (KSS) of > 90
  • Must be able to walk on level ground without aid of any kind
  • Must be able to perform deep knee bend activity without aid of any kind
  • Must be able to perform chair-rise activity without aid of any kind
  • Must be willing to sign both Informed Consent and HIPAA forms
  • Speak English

Exclusion Criteria for implanted subjects:

  • Other surgical procedures performed within the past 6 months
  • < 3 months post-operative
  • Pregnant
  • Severe cardiopulmonary or neurologic disease
  • Body weight > 250 lbs
  • BMI > 40
  • KSS < 90
  • Unable to perform 3 required activities unassisted
  • Unwilling to sign both Informed Consent and HIPAA forms
  • Prisoner
  • Mental disease
  • Unable to speak English

Inclusion Criteria for non-implanted subjects:

  • healthy, well-functioning knee with no osteoarthritis or knee pathologies
  • no other surgical procedures within the past 6 months that will prohibit them from performing the three required activities
  • Body Mass Index < 40
  • Body weight < 250 lbs
  • Not pregnant
  • Knee Society score of > 90
  • Must be able to walk on level ground without aid of any kind
  • Must be able to perform deep knee bend activity without aid of any kind
  • Must be able to perform chair-rise activity without aid of any kind
  • Must be willing to sign both Informed Consent and HIPAA forms
  • Speak English

Exclusion Criteria for non-implanted subjects:

  • Other surgical procedures performed within the past 6 months that would prohibit them from performing three required activities
  • Any past knee pathologies, osteoarthritis or knee surgeries, including implants
  • Pregnant
  • Severe cardiopulmonary or neurologic disease
  • Body weight > 250 lbs
  • BMI > 40
  • KSS < 90
  • Unable to perform 3 required activities unassisted
  • Unwilling to sign both Informed Consent and HIPAA forms
  • Prisoner
  • Mental disease
  • Unable to speak English

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Smith & Nephew Journey II BCS TKA
Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates
Device: Journey II BCS TKA
Normal knee
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kinematics Translations During Deep Knee Bend (DKB) Activity
Time Frame: 3 months post-operative
Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB
3 months post-operative
Kinematics During Deep Knee Bend (DKB) Activity
Time Frame: 3 months post-operative
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
3 months post-operative
Kinematics Translations During Squat to Stand (S2S) Activity
Time Frame: 3 months post-operative
Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S
3 months post-operative
Kinematics During Squat to Stand (S2S) Activity
Time Frame: 3 months post-operative
Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S
3 months post-operative
Kinematics Translations During Ramp up Activity
Time Frame: 3 months post-operative
AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity
3 months post-operative
Kinematics During Ramp up Activity
Time Frame: 3 months post-operative
AR of the femur during Ramp Up activity
3 months post-operative
Kinematics Translations During Ramp Down Activity
Time Frame: 3 months post-operative
AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity
3 months post-operative
Kinematics During Ramp Down Activity
Time Frame: 3 months post-operative
AR of the femur during ramp down activity
3 months post-operative

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Tennessee, Knoxville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard D Komistek, Ph D, employee

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R011373506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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