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

NCT ID: NCT04103515

Last Updated: 2021-10-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-03

Study Completion Date

2020-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects implanted with PCR TKA

Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Intervention Type DEVICE

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

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Intervention Type DEVICE

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Interventions

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Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Intervention Type DEVICE

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role lead

Responsible Party

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Richard Komistek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Komistek, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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Rothman Institute

Bryn Mawr, Pennsylvania, United States

Site Status

University of Tennessee

Knoxville, Tennessee, United States

Site Status

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

Marseille, , France

Site Status

Countries

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United States France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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WIRB20183083

Identifier Type: -

Identifier Source: org_study_id

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