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

• Sponsor: The University of Tennessee, Knoxville (Other)
• Overall Status: Completed
• CT.gov ID: NCT04103515
• Collaborator: Zimmer Biomet, Inc. (Other)
• Enrollment: 50
• Locations: 3
• Actual Duration (Months): 22.1
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee; Osteoarthritis, Knee	Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty; Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA
• Actual Study Start Date: Jan 3, 2019
• Actual Primary Completion Date: Nov 6, 2020
• Actual Study Completion Date: Nov 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; 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; Zimmer-Biomet Posterior Stabilizing total knee arthroplasty

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Bryn Mawr	Pennsylvania	United States	19010
2	University of Tennessee	Knoxville	Tennessee	United States	37996
3	The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite	Marseille		France	13009

Sponsors and Collaborators

• The University of Tennessee, Knoxville
• Zimmer Biomet, Inc.

Investigators

• Principal Investigator: Richard Komistek, PhD, University of Tennessee

Study Documents (Full-Text)

• Study Protocol - Jan 3, 2019
• Statistical Analysis Plan - Jan 3, 2019

More Information

Publications

None provided.

• Responsible Party: Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville
• ClinicalTrials.gov Identifier: NCT04103515
• Other Study ID Numbers: WIRB20183083
• First Posted: Sep 25, 2019
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Osteoarthritis, Knee; Cimetidine

Study Results

Participant Flow

Arm/Group Title	Subjects Implanted With PCR TKA	Subjects Implanted With PS TKA
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Subjects Implanted With PCR TKA	Subjects Implanted With PS TKA	Total
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	13 52%	16 64%	29 58%
Male	12 48%	9 36%	21 42%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Lateral Condyle Kinematic Translations - Step up
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With PCR TKA	Subjects Implanted With PS TKA
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Measure Participants	25	25
Mean (Standard Deviation) [mm]	1.15 (3.03)	2.28 (3.42)

2. Primary Outcome

Title	Lateral Condyle Kinematics Translations - Deep Knee Bend
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With PCR TKA	Subjects Implanted With PS TKA
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Measure Participants	25	25
Mean (Standard Deviation) [mm]	-1.52 (2.09)	-6.80 (3.47)

3. Primary Outcome

Title	Medial Condyle Kinematics Translations - Step Up
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With PCR TKA	Subjects Implanted With PS TKA
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Measure Participants	25	25
Mean (Standard Deviation) [mm]	-0.36 (2.97)	0.16 (3.91)

4. Primary Outcome

Title	Medial Condyle Kinematics Translations - Deep Knee Bend
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With PCR TKA	Subjects Implanted With PS TKA
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty	Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Measure Participants	25	25
Mean (Standard Deviation) [mm]	0.13 (2.09)	-4.25 (3.32)

Adverse Events

Time Frame	Baseline. Data is collected only on a single day, and no participant follow-up was collected. Thus, this section describes whether or not there were any adverse events on the single day of data collection
Arm/Group Title	Subjects Implanted With PCR TKA		Subjects Implanted With PS TKA
Arm/Group Description	Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty		Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
All Cause Mortality
	Subjects Implanted With PCR TKA		Subjects Implanted With PS TKA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Subjects Implanted With PCR TKA		Subjects Implanted With PS TKA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Subjects Implanted With PCR TKA		Subjects Implanted With PS TKA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.