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Completed

NCT Number: NCT04103515

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Device

Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Device

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA

Acronym: PCR PS TKA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2019
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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