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NCT04103502 | NOT YET RECRUITING | Total Knee Arthroplasty


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

The University of Tennessee, Knoxville

Information provided by (Responsible Party):

Richard Komistek

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 \[this is the location from which participants will be recruited\].

Condition or disease

Total Knee Arthroplasty

Osteo Arthritis Knee

Knee Injuries

Knee Imlant

Intervention/treatment

MicroPort Medial Pivot TKA

DePuy Attune PCR 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 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 24 participants
Official Title : In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty
Actual Study Start Date : 2024-05
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2024-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT04103502


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Nevada

Nevada Orthopedic & Spine Center

vegas, Nevada, United States, 89128

Not yet recruiting

United States, Nevada

Platinum Training/MERIN

vegas, Nevada, United States, 89130

Not yet recruiting

United States, Tennessee

The University of Tennessee

Knoxville, Tennessee, United States, 37934

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