Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)

Analysis of Competitive PCR and PS Total Knee Arthroplasty

The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith & Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Knee
• Intervention / Treatment: Device: Triathlon PCR TKA; Device: Triathlon PS TKA; Device: Persona PCR TKA; Device: Persona PS TKA

Detailed Description

The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith & Nephew PCR, BCR, and BCS TKA.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • The University of Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Tennessee Orthopaedic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a Stryker Triathlon PCR, Stryker Triathlon PS, Zimmer Persona PCR, or Zimmer Persona PS total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.

Description

Inclusion Criteria:

1. Subjects will have one of the following implant types: 1) Stryker Triathlon PCR TKA (28 subjects), 2) Stryker Triathlon PS TKA (28 subjects), 3) Zimmer Persona PCR TKA (28 subjects) and 4) Zimmer Persona PS TKA (28 subjects).
2. Patients must be at least three months post-operative.
3. Participants must not experience any pain or other post-operative complications.
4. Participants must have a stable TKA and be capable of performing a deep knee bend activity.
5. Participants must weigh less than 300 lbs., not underweight (BMI < 18.5) or too obese (BMI>35).
6. Must be in the age range of 18 years to 85 years (both inclusive).
7. Participants must be able to perform the required activities without concern.
8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.
9. Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion Criteria:

1. Pregnant, potentially pregnant, lactating females or of childbearing age. 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. (All potential female study patients will be asked if they are premenopausal or if they have undergone a hysterectomy. If the possibility of pregnancy exists, a pregnancy kit will be given to the patient at the informed consent meeting, just prior to the fluoro. Results of the test will be recorded in a test log. Any female patient showing a positive test will be excluded from testing.)
2. Subjects without the required type of knee implant.
3. Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).
4. Cannot have ligamentous pain and/or laxity.
5. Unwilling to sign IC/HIPAA form(s).
6. Does not speak English.
7. Patients who have enrolled in a fluoroscopic kinematic study within the past year.
8. Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.
9. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
10. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stryker Triathlon PCR TKA; Subjects implanted with a Stryker Triathlon PCR TKA	Device: Triathlon PCR TKA; Total Knee Arthroplasty System
Stryker Triathlon PS TKA; Subjects implanted with a Stryker Triathlon PS TKA	Device: Triathlon PS TKA; Total Knee Arthroplasty System
Zimmer Persona PCR TKA; Subjects implanted with a Zimmer Persona PCR TKA	Device: Persona PCR TKA; Total Knee Arthroplasty System
Zimmer Persona PS TKA; Subjects implanted with a Zimmer Persona PS TKA	Device: Persona PS TKA; Total Knee Arthroplasty System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity	Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.	3 months post-operative
Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity	Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.	3 months post-operative
Maximum Flexion, in Degrees, During Deep Knee Bend Activity	Maximum weight-bearing flexion, in degrees, during deep knee bend activity	3 months post-operative
Axial Rotation, in Degrees, During Deep Knee Bend Activity	Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.	3 months post-operative

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Richard Komistek, PhD, The University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 3187FB WIRB20180745 Extension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes