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CompletedNCT04321356Updated Nov 28, 2023Results posted

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

An observational study in Knee Osteoarthritis, Total Knee Arthroplasty and Knee, sponsored by The University of Tennessee, Knoxville. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by The University of Tennessee, Knoxville · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Total Knee Arthroplasty
  • Knee

Keywords

  • Total Knee Arthroplasty
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceTriathlon PCR TKA

    Total Knee Arthroplasty System

  • DeviceTriathlon PS TKA

    Total Knee Arthroplasty System

  • DevicePersona PCR TKA

    Total Knee Arthroplasty System

  • DevicePersona PS TKA

    Total Knee Arthroplasty System

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months post-operative

  2. 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.

    Time frame: 3 months post-operative

  3. Maximum Flexion, in Degrees, During Deep Knee Bend Activity

    Maximum weight-bearing flexion, in degrees, during deep knee bend activity

    Time frame: 3 months post-operative

  4. 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.

    Time frame: 3 months post-operative

07

Results

Posted Nov 28, 2023

Participant flow

Participant flow — Overall Study
MilestoneStryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKA
Started31262914
Completed31262914
Not completed0000

Outcome measures

PrimaryMedial 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.

Time frame:
3 months post-operative
Reported as:
Mean · millimeters
Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity
millimetersStryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKA
Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity4.2 ± 3.6-0.4 ± 3.4-0.5 ± 2.1-3.3 ± 4.8
PrimaryLateral 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.

Time frame:
3 months post-operative
Reported as:
Mean · millimeters
Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity
millimetersStryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKA
Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity0.7 ± 3.6-3.3 ± 3.50.6 ± 2.3-5.2 ± 4.8
PrimaryMaximum Flexion, in Degrees, During Deep Knee Bend Activity

Maximum weight-bearing flexion, in degrees, during deep knee bend activity

Time frame:
3 months post-operative
Reported as:
Mean · degrees
Maximum Flexion, in Degrees, During Deep Knee Bend Activity
degreesStryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKA
Maximum Flexion, in Degrees, During Deep Knee Bend Activity107 ± 11101 ± 16107 ± 11114 ± 17
PrimaryAxial 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.

Time frame:
3 months post-operative
Reported as:
Mean · degrees
Axial Rotation, in Degrees, During Deep Knee Bend Activity
degreesStryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKA
Axial Rotation, in Degrees, During Deep Knee Bend Activity4.3 ± 4.43.6 ± 3.7-1.5 ± 4.02.8 ± 4.7

Adverse events

Collected over Adverse events would occur and therefore are collected only during the single day of data collection. Thus, we would know right away, and therefore the specific time period is 1 day. There is no participant follow up after data collection, and participants were not monitored after data collection.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stryker Triathlon PCR TKA0/31 (0%)0/31 (0%)0/31 (0%)
Stryker Triathlon PS TKA0/26 (0%)0/26 (0%)0/26 (0%)
Zimmer Persona PCR TKA0/29 (0%)0/29 (0%)0/29 (0%)
Zimmer Persona PS TKA0/14 (0%)0/14 (0%)0/14 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Stryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKATotal
<=18 years00000
Between 18 and 65 years31262914100
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)Stryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKATotal
Female121217849
Male191412651
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Stryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKATotal
Count of participants————0
Region of Enrollment
Region of Enrollment(participants)Stryker Triathlon PCR TKAStryker Triathlon PS TKAZimmer Persona PCR TKAZimmer Persona PS TKATotal
United States31262914100
08

Study locations

2 sites
  • Tennessee Orthopaedic Clinic
    Knoxville, Tennessee 37923, United States
  • The University of Tennessee
    Knoxville, Tennessee 37996, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04321356
Lead sponsor
The University of Tennessee, Knoxville
Collaborators
Smith & Nephew, Inc.
Responsible party
Richard Komistek (Principal Investigator, The University of Tennessee, Knoxville) — Principal investigator
First posted
Mar 25, 2020
Start date
Feb 24, 2020
Primary completion
May 16, 2022
Completion
May 16, 2022
Results posted
Nov 28, 2023
Last update
Nov 28, 2023

Study contacts

Richard Komistek, PhD
principal investigator · The University of Tennessee

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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