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Clinical Trials/NCT04103502
NCT04103502
Not Yet Recruiting
N/A

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

The University of Tennessee, Knoxville3 sites in 1 country24 target enrollmentMay 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
The University of Tennessee, Knoxville
Enrollment
24
Locations
3
Primary Endpoint
Kinematics during step up activity
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2024
End Date
December 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
The University of Tennessee, Knoxville
Responsible Party
Principal Investigator
Principal Investigator

Richard Komistek

Fred M. Roddy Professor of Biomedical Engineering

The University of Tennessee, Knoxville

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Kinematics during step up activity

Time Frame: at least 6 months post-operative

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

Kinematics Translations during Deep Knee Bend Activity

Time Frame: at least 6 months post-operative

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

Kinematics during Deep Knee Bend Activity

Time Frame: at least 6 months post-operative

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

Kinematics Translations during step up activity

Time Frame: at least 6 months post-operative

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

Study Sites (3)

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