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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088748
• Other study ID #: 3187FB WIRB20180745
• Status: Completed
• Start date: January 2017
• Est. completion date: November 9, 2020

Study information

• Verified date: October 2021
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis, Knee

Intervention

Device:
• Journey II posterior cruciate retaining total knee arthroplasty

• Journey II posterior bi-cruciate retaining total knee arthroplasty

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Tennessee Foundation for Education and Research	Knoxville	Tennessee
United States	Tennessee Orthopaedic Clinic	Knoxville	Tennessee
United States	The University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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