Status:
COMPLETED
In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)
Lead Sponsor:
The University of Tennessee, Knoxville
Collaborating Sponsors:
Hofmann Arthritis Institute
Duke University
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 a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center fo...
Detailed Description
Enrollment will be increased to 24 subjects 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. At pre...
Eligibility Criteria
Inclusion
- Subjects will have a Klassic knee system.
- Subjects must be at least six months post-operative.
- Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than 80.
- Participants must be able to perform a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
- Must speak English.
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 the required type of knee implant.
- Bilateral subjects (i.e., patients with both knees implanted)
- Subjects who are unable to perform a deep knee bend.
- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- Subjects who do not speak English
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 5 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04113785
Start Date
October 1 2018
End Date
June 5 2019
Last Update
November 15 2019
Active Locations (1)
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1
Hofmann Arthritis Institute for Precision Joint Replacement
Salt Lake City, Utah, United States, 84102