Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

The University of Tennessee, Knoxville

Collaborating Sponsors:

MicroPort Orthopedics Inc.

Conditions:

Total Knee Arthroplasty

Osteo Arthritis Knee

Eligibility:

All Genders

18+ years

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) ...

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT04103502

Start Date

May 1 2024

End Date

December 1 2024

Last Update

May 10 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Nevada Orthopedic & Spine Center

Las Vegas, Nevada, United States, 89128

2

Platinum Training/MERIN

Las Vegas, Nevada, United States, 89130

3

The University of Tennessee

Knoxville, Tennessee, United States, 37934

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