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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
Sponsor:
Collaborator:
Zimmer Biomet, Inc.
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

Study Description
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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.

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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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
Study Population
Patients implanted with a Zimmer-Biomet posterior cruciate retaining (PCR) or Zimmer-Biomet posterior stabilizing total knee arthroplasty (TKA)
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 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
The University of Tennessee, Knoxville
Zimmer Biomet, Inc.
Investigators
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Principal Investigator: Richard Komistek, PhD University of Tennessee
  Study Documents (Full-Text)

Documents provided by Richard Komistek, The University of Tennessee, Knoxville:
Study Protocol  [PDF] January 3, 2019
Statistical Analysis Plan  [PDF] January 3, 2019

More Information
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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.

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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
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
 Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors