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Completed

NCT Number: NCT03088748

Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements

The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith & Nephew BCS TKA and compared these kinematics data to those of normal knees.

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Key information

Conditions

Arthroplasty, Replacement, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erlanger Health System, Chattanooga, Tennessee, United States

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About this study

The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Journey II PCR or BCR TKA and compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith & Nephew Journey II BCS TKA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have must either a Smith & Nephew Journey II PCR or BCR TKA
  • Must be at least three months post-operative
  • Must have a Knee Society score of >90 with no ligamentous laxity or pain
  • Weigh 250 pounds or less
  • Should have good-to-excellent post-operative flexion
  • Must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend
  • Must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
  • Must have body mass index (BMI) of less than 38
  • Must be between 40-85 years of age
  • Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms to participate in the study

Exclusion criteria

  • 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
  • Subjects without the required types of knee implants
  • Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain
  • Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities

Treatment and study plan

Journey II posterior cruciate retaining total knee arthroplasty

Device

Other names: Journey II PCR TKA

Journey II posterior bi-cruciate retaining total knee arthroplasty

Device

Other names: Journey II BCR TKA

Primary outcomes

  1. Lateral Kinematics Translations While Ascending Ramp

    Time frame: Baseline

    Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  2. Medial Kinematics Translations While Ascending Ramp

    Time frame: Baseline

    Anterior Posterior (AP) translations of medial femoral condyles during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  3. Axial Rotation While Ascending Ramp

    Time frame: Baseline

    Femorotibial axial rotation during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  4. Lateral Kinematics Translations While Descending Ramp

    Time frame: Baseline

    Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  5. Medial Kinematics Translations While Descending Ramp

    Time frame: Baseline

    Anterior Posterior (AP) translations of medial femoral condyles during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  6. Axial Rotation While Descending Ramp

    Time frame: Baseline

    Femorotibial axial rotation during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  7. Lateral Kinematics Translations During Deep Knee Bend

    Time frame: Baseline

    Anterior Posterior (AP) translations of lateral femoral condyles during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  8. Medial Kinematics Translations During Deep Knee Bend

    Time frame: Baseline

    Anterior Posterior (AP) translations of medial femoral condyles during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  9. Axial Rotation During Deep Knee Bend

    Time frame: Baseline

    Femorotibial axial rotation during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

  10. Maximum Flexion During Deep Knee Bend

    Time frame: Baseline

    Maximum weight-bearing femorotibial flexion during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial range of motion) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive values are the only possible values in this case, representing the magnitude of weight-bearing flexion. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2017
Registry last updated
Oct 12, 2021

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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