Trial Outcomes & Findings for Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty (NCT NCT04103515)

Results Overview

Lateral Condyle Kinematics Translations during stepping up activity. 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 step 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	Subjects Implanted With PCR TKA Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects Implanted With PS TKA Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
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	Subjects Implanted With PCR TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects Implanted With PS TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Sex: Female, Male Female	13 Participants n=25 Participants	16 Participants n=25 Participants	29 Participants n=50 Participants
Sex: Female, Male Male	12 Participants n=25 Participants	9 Participants n=25 Participants	21 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline

Lateral Condyle Kinematics Translations during stepping up activity. 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 step 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	Subjects Implanted With PCR TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects Implanted With PS TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Lateral Condyle Kinematic Translations - Step up	1.15 mm Standard Deviation 3.03	2.28 mm Standard Deviation 3.42

PRIMARY outcome

Timeframe: Baseline

Lateral Condyle Kinematics Translations during deep knee bend activity. 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	Subjects Implanted With PCR TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects Implanted With PS TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Lateral Condyle Kinematics Translations - Deep Knee Bend	-1.52 mm Standard Deviation 2.09	-6.80 mm Standard Deviation 3.47

PRIMARY outcome

Timeframe: Baseline

Medial Condyle Kinematics Translations during stepping up activity. 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 step 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	Subjects Implanted With PCR TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects Implanted With PS TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Medial Condyle Kinematics Translations - Step Up	-0.36 mm Standard Deviation 2.97	0.16 mm Standard Deviation 3.91

PRIMARY outcome

Timeframe: Baseline

Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. 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	Subjects Implanted With PCR TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects Implanted With PS TKA n=25 Participants Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Medial Condyle Kinematics Translations - Deep Knee Bend	0.13 mm Standard Deviation 2.09	-4.25 mm Standard Deviation 3.32

Adverse Events

Subjects Implanted With PCR TKA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects Implanted With PS 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