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

NCT03088748 | Completed Results DMC FDA Device

• 1 other identifier: 3187FB WIRB20180745
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee; Osteoarthritis, Knee

Keywords

total knee arthroplasty

Outcome Measures

Primary Outcomes (10)

• Lateral Kinematics Translations While Ascending Ramp

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Smith & Nephew Journey II PCR TKA

Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty

Device: Journey II posterior cruciate retaining total knee arthroplasty

Smith & Nephew Journey II BCR TKA

Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty

Device: Journey II posterior bi-cruciate retaining total knee arthroplasty

Interventions

Journey II posterior cruciate retaining total knee arthroplasty DEVICE

Also known as: Journey II PCR TKA

Smith & Nephew Journey II PCR TKA

Journey II posterior bi-cruciate retaining total knee arthroplasty DEVICE

Also known as: Journey II BCR TKA

Smith & Nephew Journey II BCR TKA

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (4)

Erlanger Health System

Chattanooga, Tennessee, 34703, United States

Location

Tennessee Foundation for Education and Research

Knoxville, Tennessee, 37923, United States

Location

Tennessee Orthopaedic Clinic

Knoxville, Tennessee, 37923, United States

Location

The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Michael LaCour
• Organization: University of Tennessee

mlacour@utk.edu

8659742093

Study Officials

• Richard Komistek

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 23, 2017
• Study Start: January 1, 2017
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)