Trial Outcomes & Findings for Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements (NCT NCT03088748)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Baseline

Results posted on

2021-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Smith & Nephew Journey II PCR TKA Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty 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 Journey II posterior bi-cruciate retaining total knee arthroplasty
Overall Study STARTED	40	10
Overall Study COMPLETED	40	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty	Total n=50 Participants Total of all reporting groups
Age, Continuous	67.4 years STANDARD_DEVIATION 7.55 • n=40 Participants	62.3 years STANDARD_DEVIATION 4.32 • n=10 Participants	66.3 years STANDARD_DEVIATION 7.26 • n=50 Participants
Sex: Female, Male Female	27 Participants n=40 Participants	5 Participants n=10 Participants	32 Participants n=50 Participants
Sex: Female, Male Male	13 Participants n=40 Participants	5 Participants n=10 Participants	18 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Lateral Kinematics Translations While Ascending Ramp	0.1 mm Standard Deviation 5.9	-0.4 mm Standard Deviation 3.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Medial Kinematics Translations While Ascending Ramp	-1.8 mm Standard Deviation 3.9	-2.0 mm Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Axial Rotation While Ascending Ramp	-2.6 degrees Standard Deviation 6.3	-2.0 degrees Standard Deviation 4.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Lateral Kinematics Translations While Descending Ramp	0.1 mm Standard Deviation 6.4	-6.3 mm Standard Deviation 7.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Medial Kinematics Translations While Descending Ramp	-1.0 mm Standard Deviation 3.4	-3.2 mm Standard Deviation 3.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Axial Rotation While Descending Ramp	-1.2 degrees Standard Deviation 6.2	3.7 degrees Standard Deviation 7.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Lateral Kinematics Translations During Deep Knee Bend	-3.7 mm Standard Deviation 5.8	-9.4 mm Standard Deviation 6.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Medial Kinematics Translations During Deep Knee Bend	1.0 mm Standard Deviation 4.2	-4.4 mm Standard Deviation 3.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Axial Rotation During Deep Knee Bend	5.9 degrees Standard Deviation 5.7	6.0 degrees Standard Deviation 7.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smith & Nephew Journey II PCR TKA n=40 Participants Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Journey II posterior cruciate retaining total knee arthroplasty	Smith & Nephew Journey II BCR TKA n=10 Participants Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Journey II posterior bi-cruciate retaining total knee arthroplasty
Maximum Flexion During Deep Knee Bend	112.3 degrees Standard Deviation 14.0	105.4 degrees Standard Deviation 12.8

Adverse Events

Smith & Nephew Journey II PCR TKA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smith & Nephew Journey II BCR TKA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael LaCour

University of Tennessee

Phone: 8659742093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place