Clinical trial NCT04103515: Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty
Official title: In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Knee
Osteoarthritis, Knee
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2019-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a Zimmer-Biomet posterior cruciate retaining (PCR) or Zimmer-Biomet posterior stabilizing total knee arthroplasty (TKA)

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 to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.


Eligibility criteria: Inclusion Criteria:

* 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 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. 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

Primary outcomes:
measure: Lateral Condyle Kinematic Translations - Step up
timeFrame: Baseline
measure: Lateral Condyle Kinematics Translations - Deep Knee Bend
timeFrame: Baseline
measure: Medial Condyle Kinematics Translations - Step Up
timeFrame: Baseline
measure: Medial Condyle Kinematics Translations - Deep Knee Bend
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Marseille
country: France
facility: The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite
Study officials:
affiliation: University of Tennessee
name: Richard Komistek, PhD
role: PRINCIPAL_INVESTIGATOR
References: