Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty (PCR PS TKA)

The University of Tennessee, Knoxville

Status: Completed

Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee

Treatments: Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty; Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT04103515

WIRB20183083

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Subjects implanted with PCR TKA

Description:

Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Treatment:

Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Subjects implanted with PS TKA

Description:

Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Treatment:

Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty