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

October 11, 2021 updated by: Richard Komistek, The University of Tennessee, Knoxville
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.

Study Overview

Detailed Description

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.

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

    • Tennessee
      • Chattanooga, Tennessee, United States, 34703
        • Erlanger Health System
      • Knoxville, Tennessee, United States, 37996
        • The University of Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Tennessee Foundation for Education and Research
      • 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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with a Smith & Nephew Journey II posterior cruciate retaining (PCR) or a Smith & Nephew Journey II bi-cruciate retaining (BCR) total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.

Description

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

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 PCR TKA
Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty
Other Names:
  • Journey II PCR TKA
Smith & Nephew Journey II BCR TKA
Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty
Other Names:
  • Journey II BCR TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Richard Komistek, 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)

January 1, 2017

Primary Completion (ACTUAL)

November 9, 2020

Study Completion (ACTUAL)

November 9, 2020

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (ACTUAL)

March 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 3187FB WIRB20180745

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

product manufactured in and exported from the U.S.

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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