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

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ClinicalTrials.gov Identifier: NCT04321356
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

Brief Summary:
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.

Condition or disease Intervention/treatment
Knee Osteoarthritis Total Knee Arthroplasty Knee 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.

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Study Type : Observational
Estimated Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Competitive PCR and PS Total Knee Arthroplasty
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. Maximum Flexion, in degrees, while ascending ramp [ Time Frame: 3 months post-operative ]
    Maximum weight-bearing flexion, in degrees, while walking up a ramp

  4. Axial Rotation, in degrees, while ascending ramp [ Time Frame: 3 months post-operative ]
    Axial rotation (AR), in degrees, while walking up a ramp

  5. 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

  6. 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

  7. Maximum Flexion, in degrees, while descending ramp [ Time Frame: 3 months post-operative ]
    Maximum weight-bearing flexion, in degrees, while walking down a ramp

  8. Axial Rotation, in degrees, while descending ramp [ Time Frame: 3 months post-operative ]
    Axial rotation (AR), in degrees, while walking down a ramp

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Maximum Flexion, in degrees, during S2S activity [ Time Frame: 3 months post-operative ]
    Maximum weight-bearing flexion, in degrees, during S2S activity

  16. Axial Rotation, in degrees, during S2S activity [ Time Frame: 3 months post-operative ]
    Axial rotation (AR), in degrees, during S2S activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321356


Contacts
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Contact: Richard Komistek, PhD 8659744159 rkomiste@utk.edu
Contact: Michael LaCour mlacour@utk.edu

Locations
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United States, Tennessee
Tennessee Orthopaedic Clinic Recruiting
Knoxville, Tennessee, United States, 37923
Contact: Harold Cates, MD    865-690-4861    cateshe@tocdocs.com   
Contact: Jane Smith    8653731811    smithjo@tocdocs.com   
Principal Investigator: Harold Cates         
The University of Tennessee Not yet recruiting
Knoxville, Tennessee, United States, 37996
Contact: Richard Komistek, PhD    865-974-4159    rkomiste@utk.edu   
Contact: Michael LaCour       mlacour@utk.edu   
Principal Investigator: Richard Komistek         
Sub-Investigator: Michael LaCour         
Sponsors and Collaborators
The University of Tennessee, Knoxville
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Richard Komistek, PhD The University of Tennessee
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Responsible Party: Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT04321356    
Other Study ID Numbers: 3187FB WIRB20180745 Extension
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Richard Komistek, The University of Tennessee, Knoxville:
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases