In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA

NCT ID: NCT04103502

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-12-31

Brief Summary

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In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic \& Spine Center \[this is the location from which participants will be recruited\].

Detailed Description

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There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.

Conditions

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Total Knee Arthroplasty Osteo Arthritis Knee Knee Injuries Knee Imlant

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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MicroPort Medial Pivot

Subjects will have been implanted with the MicroPort Medial Pivot TKA

MicroPort Medial Pivot TKA

Intervention Type DEVICE

Subjects will have been implanted with the MicroPort Medial Pivot TKA

DePuy Attune

Subjects will have been implanted with the DePuy Attune PCR TKA

DePuy Attune PCR TKA

Intervention Type DEVICE

Subjects will have been implanted with the DePuy Attune PCR TKA

Interventions

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MicroPort Medial Pivot TKA

Subjects will have been implanted with the MicroPort Medial Pivot TKA

Intervention Type DEVICE

DePuy Attune PCR TKA

Subjects will have been implanted with the DePuy Attune PCR TKA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.
* Subjects must be at least six months post-operative.
* Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.
* 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

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.
* Subjects without one of the two types of knee implants under investigation.
* Subjects who are unable to perform stepping up and deep knee bend.
* Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
* Does not speak English.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role lead

Responsible Party

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Richard Komistek

Fred M. Roddy Professor of Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Komistek, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee

Locations

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Nevada Orthopedic & Spine Center

Las Vegas, Nevada, United States

Site Status

Platinum Training/MERIN

Las Vegas, Nevada, United States

Site Status

The University of Tennessee

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Central Contacts

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Richard Komistek, Ph.D.

Role: CONTACT

8659744159

Rebecca Robertson, MLIS

Role: CONTACT

8659742093

Facility Contacts

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Russell Nevins, MD

Role: primary

702-258-3773

Prisma Limon

Role: backup

(702) 258-3773

Amy Oddo

Role: primary

702-856-2601

Richard Komistek, PhD

Role: primary

865-974-4159

Rebecca Robertson, MLIS

Role: backup

8659742093

Other Identifiers

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WIRB20181868

Identifier Type: -

Identifier Source: org_study_id

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