Status:
COMPLETED
Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty
Lead Sponsor:
The University of Tennessee, Knoxville
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Arthroplasty, Replacement, Knee
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Brief Summary
25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked ...
Eligibility Criteria
Inclusion
- Subjects will have a Zimmer Persona PCR or PS TKA.
- Subjects must be at least six months post-operative.
- Subjects will have KSS greater than 75.
- 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.
- Bilateral subjects may be included in the subject population
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. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy.
- Subjects without the required type of knee implant.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who do not speak English and/or French
Key Trial Info
Start Date :
January 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 6 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04103515
Start Date
January 3 2019
End Date
November 6 2020
Last Update
October 12 2021
Active Locations (3)
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1
Rothman Institute
Bryn Mawr, Pennsylvania, United States, 19010
2
University of Tennessee
Knoxville, Tennessee, United States, 37996
3
The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite
Marseille, France, 13009