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

Overview

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.

Full Title of Study: “Analysis of Competitive PCR and PS Total Knee Arthroplasty”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 31, 2020

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.

Interventions

  • Device: Triathlon PCR TKA
    • Total Knee Arthroplasty System
  • Device: Triathlon PS TKA
    • Total Knee Arthroplasty System
  • Device: Persona PCR TKA
    • Total Knee Arthroplasty System
  • Device: Persona PS TKA
    • Total Knee Arthroplasty System

Arms, Groups and Cohorts

  • Stryker Triathlon PCR TKA
    • Subjects implanted with a Stryker Triathlon PCR TKA
  • Stryker Triathlon PS TKA
    • Subjects implanted with a Stryker Triathlon PS TKA
  • Zimmer Persona PCR TKA
    • Subjects implanted with a Zimmer Persona PCR TKA
  • Zimmer Persona PS TKA
    • Subjects implanted with a Zimmer Persona PS TKA

Clinical Trial Outcome Measures

Primary Measures

  • Medial AP Translations, in mm, while ascending ramp
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of medial femoral condyle during activity of walking up a ramp
  • Lateral AP Translations, in mm, while ascending ramp
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during activity of walking up a ramp
  • Maximum Flexion, in degrees, while ascending ramp
    • Time Frame: 3 months post-operative
    • Maximum weight-bearing flexion, in degrees, while walking up a ramp
  • Axial Rotation, in degrees, while ascending ramp
    • Time Frame: 3 months post-operative
    • Axial rotation (AR), in degrees, while walking up a ramp
  • Medial AP Translations, in mm, while descending ramp
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of medial femoral condyle during activity of walking down a ramp
  • Lateral AP Translations, in mm, while descending ramp
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during activity of walking down a ramp
  • Maximum Flexion, in degrees, while descending ramp
    • Time Frame: 3 months post-operative
    • Maximum weight-bearing flexion, in degrees, while walking down a ramp
  • Axial Rotation, in degrees, while descending ramp
    • Time Frame: 3 months post-operative
    • Axial rotation (AR), in degrees, while walking down a ramp
  • Medial AP Translations, in mm, during deep knee bend (DKB) activity
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity
  • Lateral AP Translations, in mm, during deep knee bend (DKB) activity
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity
  • Maximum Flexion, in degrees, during deep knee bend activity
    • Time Frame: 3 months post-operative
    • Maximum weight-bearing flexion, in degrees, during deep knee bend activity
  • Axial Rotation, in degrees, during deep knee bend activity
    • Time Frame: 3 months post-operative
    • Axial rotation (AR), in degrees, during deep knee bend activity
  • Medial AP Translations, in mm, during squat to stand (S2S) activity
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of medial femoral condyle during during S2S activity
  • Lateral AP Translations, in mm, during squat to stand (S2S) activity
    • Time Frame: 3 months post-operative
    • Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during during S2S activity
  • Maximum Flexion, in degrees, during S2S activity
    • Time Frame: 3 months post-operative
    • Maximum weight-bearing flexion, in degrees, during S2S activity
  • Axial Rotation, in degrees, during S2S activity
    • Time Frame: 3 months post-operative
    • Axial rotation (AR), in degrees, during S2S activity

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Tennessee, Knoxville
  • Collaborator
    • Smith & Nephew, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard Komistek, Principal Investigator – The University of Tennessee, Knoxville
  • Overall Official(s)
    • Richard Komistek, PhD, Principal Investigator, The University of Tennessee
  • Overall Contact(s)
    • Richard Komistek, PhD, 8659744159, rkomiste@utk.edu

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