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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

The University of Tennessee, Knoxville

Collaborators

Smith & Nephew, Inc.

Investigators

  • 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

July 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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