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Completed

NCT Number: NCT04321356

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee Orthopaedic Clinic, Knoxville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Patients must be at least three months post-operative.
  • Participants must not experience any pain or other post-operative complications.
  • Participants must have a stable TKA and be capable of performing a deep knee bend activity.
  • Participants must weigh less than 300 lbs., not underweight (BMI < 18.5) or too obese (BMI>35).
  • Must be in the age range of 18 years to 85 years (both inclusive).
  • Participants must be able to perform the required activities without concern.
  • Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.
  • Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion criteria

  • 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.)
  • Subjects without the required type of knee implant.
  • Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).
  • Cannot have ligamentous pain and/or laxity.
  • Unwilling to sign IC/HIPAA form(s).
  • Does not speak English.
  • Patients who have enrolled in a fluoroscopic kinematic study within the past year.
  • Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.
  • Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
  • Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.

Treatment and study plan

Triathlon PCR TKA

Device

Total Knee Arthroplasty System

Triathlon PS TKA

Device

Total Knee Arthroplasty System

Persona PCR TKA

Device

Total Knee Arthroplasty System

Persona PS TKA

Device

Total Knee Arthroplasty System

Primary outcomes

  1. 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. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.

  2. 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. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.

  3. 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

  4. 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. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Official study title

Analysis of Competitive PCR and PS Total Knee Arthroplasty

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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