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

In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04103502
Acronym
TKA PCR
Enrollment
0
Registered
2019-09-25
Start date
2025-05-01
Completion date
2025-12-15
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Imlant, Knee Injuries, Osteo Arthritis Knee, Total Knee Arthroplasty

Brief summary

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

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.

Interventions

DEVICEMicroPort Medial Pivot TKA

Subjects will have been implanted with the MicroPort Medial Pivot TKA

DEVICEDePuy Attune PCR TKA

Subjects will have been implanted with the DePuy Attune PCR TKA

Sponsors

The University of Tennessee, Knoxville
Lead SponsorOTHER
MicroPort Orthopedics Inc.
CollaboratorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Kinematics Translations during Deep Knee Bend Activityat least 6 months post-operativeAnterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend
Kinematics during Deep Knee Bend Activityat least 6 months post-operativeMaximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Kinematics Translations during step up activityat least 6 months post-operativeAnterior Posterior (AP) translations of lateralfemoral condyles during step up activity
Kinematics during step up activityat least 6 months post-operativeMaximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRichard Komistek, Ph.D.

The University of Tennessee

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026