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

Not yet recruiting
Conditions
Knee Injuries
Knee Imlant
Osteo Arthritis Knee
Total Knee Arthroplasty
Interventions
Device: MicroPort Medial Pivot TKA
Device: DePuy Attune PCR TKA
Registration Number
NCT04103502
Lead Sponsor
The University of Tennessee, Knoxville
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
24
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
MicroPort Medial PivotMicroPort Medial Pivot TKASubjects will have been implanted with the MicroPort Medial Pivot TKA
DePuy AttuneDePuy Attune PCR TKASubjects will have been implanted with the DePuy Attune PCR TKA
Primary Outcome Measures
NameTimeMethod
Kinematics during step up activityat least 6 months post-operative

Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity

Kinematics Translations during Deep Knee Bend Activityat least 6 months post-operative

Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend

Kinematics during Deep Knee Bend Activityat least 6 months post-operative

Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB

Kinematics Translations during step up activityat least 6 months post-operative

Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Nevada Orthopedic & Spine Center

🇺🇸

Las Vegas, Nevada, United States

Platinum Training/MERIN

🇺🇸

Las Vegas, Nevada, United States

The University of Tennessee

🇺🇸

Knoxville, Tennessee, United States

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