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

Completed

• Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee
• Interventions: Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty; Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

• Registration Number: NCT04103515
• Lead Sponsor: The University of Tennessee, Knoxville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Results First Submitted: 2021-05-10
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Results First Posted: 2021-10-12
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects implanted with PCR TKA	Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
Subjects implanted with PS TKA	Zimmer-Biomet Posterior Stabilizing total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Primary Outcome Measures

Name	Time	Method
Medial Condyle Kinematics Translations - Deep Knee Bend	Baseline	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.
Lateral Condyle Kinematics Translations - Deep Knee Bend	Baseline	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.
Lateral Condyle Kinematic Translations - Step up	Baseline	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.
Medial Condyle Kinematics Translations - Step Up	Baseline	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.

Trial Locations

Locations (3)

Rothman Institute; 🇺🇸 Bryn Mawr, Pennsylvania, United States

University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite; 🇫🇷 Marseille, France