Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty (PCR PS TKA)
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ClinicalTrials.gov Identifier: NCT04103515 |
Recruitment Status :
Completed
First Posted : September 25, 2019
Results First Posted : October 12, 2021
Last Update Posted : October 12, 2021
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Condition or disease | Intervention/treatment |
---|---|
Arthroplasty, Replacement, Knee Osteoarthritis, Knee | Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
Study Type : | Observational |
Actual Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA |
Actual Study Start Date : | January 3, 2019 |
Actual Primary Completion Date : | November 6, 2020 |
Actual Study Completion Date : | November 6, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Subjects implanted with PCR TKA
Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
|
Device: 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
|
Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
- Lateral Condyle Kinematic Translations - Step up [ Time Frame: 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.
- Lateral Condyle Kinematics Translations - Deep Knee Bend [ Time Frame: 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.
- Medial Condyle Kinematics Translations - Step Up [ Time Frame: 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.
- Medial Condyle Kinematics Translations - Deep Knee Bend [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects will have a Zimmer Persona PCR or PS TKA.
- Subjects must be at least six months post-operative.
- Subjects will have KSS greater than 75.
- Participants must be able to perform the required activities - stepping up and a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
- Bilateral subjects may be included in the subject population
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. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy.
- Subjects without the required type of knee implant.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who do not speak English and/or French

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103515
United States, Pennsylvania | |
Rothman Institute | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
United States, Tennessee | |
University of Tennessee | |
Knoxville, Tennessee, United States, 37996 | |
France | |
The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite | |
Marseille, France, 13009 |
Principal Investigator: | Richard Komistek, PhD | University of Tennessee |
Documents provided by Richard Komistek, The University of Tennessee, Knoxville:
Responsible Party: | Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville |
ClinicalTrials.gov Identifier: | NCT04103515 |
Other Study ID Numbers: |
WIRB20183083 |
First Posted: | September 25, 2019 Key Record Dates |
Results First Posted: | October 12, 2021 |
Last Update Posted: | October 12, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
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