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

NCT04103515 | Completed Results FDA Device

• 1 other identifier: WIRB20183083
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 3

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.

Conditions

Arthroplasty, Replacement, Knee; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Subjects implanted with PCR TKA

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

Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Subjects implanted with PS TKA

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

Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Interventions

Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty DEVICE

Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty

Subjects implanted with PCR TKA

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty DEVICE

Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Subjects implanted with PS TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Zimmer Biomet: collaborator

Study Sites (3)

Rothman Institute

Bryn Mawr, Pennsylvania, 19010, United States

Location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite

Marseille, 13009, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Michael LaCour
• Organization: University of Tennessee

mlacour@utk.edu

8659742093

Study Officials

• Richard Komistek, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: January 3, 2019
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); FR (1)