Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty (PCR PS TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103515
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Zimmer Biomet, Inc.
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 56 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Kinematics Translations - step up [ Time Frame: at least 6 months post-operative ]
    Kinematics Translations during stepping up activity

  2. Kinematics Translations - deep knee bend [ Time Frame: at least 6 months post-operative ]
    Kinematics Translations during deep knee bend activity


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Contacts
Layout table for location contacts
Contact: Richard Komistek, PhD 865-974-4159 rkomiste@utk.edu
Contact: Michael LaCour, PhD 864-974-7684 mlacour@utk.edu

Locations
Layout table for location information
United States, Pennsylvania
Rothman Institute Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Jess Lonner, MD    267-339-7818    Jess.Lonner@rothmanortho.com   
Contact: Tiffany Morrison    267-339-7818    Tiffany.Morrison@rothmanortho.com   
Principal Investigator: Jess Lonner, MD         
United States, Tennessee
University of Tennessee Active, not recruiting
Knoxville, Tennessee, United States, 37996
France
The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite Active, not recruiting
Marseille, France, 13009
Sponsors and Collaborators
The University of Tennessee, Knoxville
Zimmer Biomet, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Richard Komistek, PhD University of Tennessee
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Last Update Posted: October 10, 2019
Last Verified: October 2019
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.

Layout table for additional information
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:
Layout table for MeSH terms
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