Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

— PCR PS TKA  

Official title:

In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103515
• Other study ID #: WIRB20183083
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: November 6, 2020

Study information

• Verified date: October 2021
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
France	The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite	Marseille
United States	Rothman Institute	Bryn Mawr	Pennsylvania
United States	University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Zimmer Biomet, Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateral Condyle Kinematic Translations - Step up	Lateral Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.	Baseline
Primary	Lateral Condyle Kinematics Translations - Deep Knee Bend	Lateral Condyle Kinematics Translations during deep knee bend activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.	Baseline
Primary	Medial Condyle Kinematics Translations - Step Up	Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.	Baseline
Primary	Medial Condyle Kinematics Translations - Deep Knee Bend	Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.	Baseline