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Clinical Trials/NCT04103515
NCT04103515
Completed
Not Applicable

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

The University of Tennessee, Knoxville3 sites in 2 countries50 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty, Replacement, Knee
Sponsor
The University of Tennessee, Knoxville
Enrollment
50
Locations
3
Primary Endpoint
Lateral Condyle Kinematics Translations - Deep Knee Bend
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
November 6, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The University of Tennessee, Knoxville
Responsible Party
Principal Investigator
Principal Investigator

Richard Komistek

Principal Investigator

The University of Tennessee, Knoxville

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

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 - 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.

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.

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.

Study Sites (3)

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