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

NCT04321356 | Completed Results DMC FDA Device

• 1 other identifier: 3187FB WIRB20180745 Extension
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty; Knee

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Stryker Triathlon PCR TKA

Subjects implanted with a Stryker Triathlon PCR TKA

Device: Triathlon PCR TKA

Stryker Triathlon PS TKA

Subjects implanted with a Stryker Triathlon PS TKA

Device: Triathlon PS TKA

Zimmer Persona PCR TKA

Subjects implanted with a Zimmer Persona PCR TKA

Device: Persona PCR TKA

Zimmer Persona PS TKA

Subjects implanted with a Zimmer Persona PS TKA

Device: Persona PS TKA

Interventions

Triathlon PCR TKA DEVICE

Total Knee Arthroplasty System

Stryker Triathlon PCR TKA

Triathlon PS TKA DEVICE

Total Knee Arthroplasty System

Stryker Triathlon PS TKA

Persona PCR TKA DEVICE

Total Knee Arthroplasty System

Zimmer Persona PCR TKA

Persona PS TKA DEVICE

Total Knee Arthroplasty System

Zimmer Persona PS TKA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (2)

Tennessee Orthopaedic Clinic

Knoxville, Tennessee, 37923, United States

Location

The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Michael LaCour
• Organization: University of Tennessee

mlacour@utk.edu

865-974-9376

Study Officials

• Richard Komistek, PhD

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: March 25, 2020
• Study Start: February 24, 2020
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)