NCT04103515: PCR PS TKA

Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty

Completed Results posted Last updated 12 October 2021

What this trial tests

trial testing Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty in Arthroplasty, Replacement, Knee in 50 participants. Completed in 6 November 2020.

Timeline

3 January 2019

Primary endpoint
6 November 2020

6 November 2020

Quick facts

Lead sponsor	The University of Tennessee, Knoxville
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	3 January 2019
Primary completion	6 November 2020
Estimated completion	6 November 2020
Sites	3 locations across France, United States

Drugs / interventions tested

• Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
• Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Conditions studied

• Arthroplasty, Replacement, Knee — all drugs for Arthroplasty, Replacement, Knee →
• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

The University of Tennessee, Knoxville

Who can join

18 and older, any sex, with Arthroplasty, Replacement, Knee or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lateral Condyle Kinematic Translations - Step up Primary · 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.

Group	Value	95% CI
Subjects Implanted With PCR TKA	1.15	± 3.03
Subjects Implanted With PS TKA	2.28	± 3.42

Lateral Condyle Kinematics Translations - Deep Knee Bend Primary · 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.

Group	Value	95% CI
Subjects Implanted With PCR TKA	-1.52	± 2.09
Subjects Implanted With PS TKA	-6.80	± 3.47

Medial Condyle Kinematics Translations - Step Up Primary · 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.

Group	Value	95% CI
Subjects Implanted With PCR TKA	-0.36	± 2.97
Subjects Implanted With PS TKA	0.16	± 3.91

Medial Condyle Kinematics Translations - Deep Knee Bend Primary · 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 fe

Group	Value	95% CI
Subjects Implanted With PCR TKA	0.13	± 2.09
Subjects Implanted With PS TKA	-4.25	± 3.32

Sponsor's own description

25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.