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Completed

NCT Number: NCT02335710

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

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.

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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee Orthopaedic Clinic, Knoxville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Journey II BCS TKA

Device

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

  5. 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

  6. Kinematics During Ramp up Activity

    Time frame: 3 months post-operative

    AR of the femur during Ramp Up activity

  7. 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

  8. Kinematics During Ramp Down Activity

    Time frame: 3 months post-operative

    AR of the femur during ramp down activity

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2015
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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