Knee OsteoarthritisNCT04321356

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

An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by The University of Tennessee, Knoxville at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Knee Osteoarthritis, Total Knee Arthroplasty, Knee
What is being tested?: Triathlon PCR TKA, Triathlon PS TKA and Persona PCR TKA
Type of treatment: Medical device
How many people: 100 participants
Where: 2 sitesUnited States
Study dates: 24 Feb 2020to 16 May 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Tennessee Orthopaedic Clinic
Knoxville, Tennessee, 37923
The University of Tennessee
Knoxville, Tennessee, 37996

Other trials in United States

About this study

Official title: Analysis of Competitive PCR and PS Total Knee Arthroplasty

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.

Conditions: Knee Osteoarthritis, Total Knee Arthroplasty, Knee
Being tested: Triathlon PCR TKA, Triathlon PS TKA, Persona PCR TKA, Persona PS TKA
Keywords: Total Knee Arthroplasty
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triathlon PCR TKADevice
Total Knee Arthroplasty System
Triathlon PS TKADevice
Total Knee Arthroplasty System
Persona PCR TKADevice
Total Knee Arthroplasty System
Persona PS TKADevice
Total Knee Arthroplasty System

Study groups in NCT04321356
Study group	Role	What they receive
Stryker Triathlon PCR TKA		Subjects implanted with a Stryker Triathlon PCR TKA Receives: Device: Triathlon PCR TKA
Stryker Triathlon PS TKA		Subjects implanted with a Stryker Triathlon PS TKA Receives: Device: Triathlon PS TKA
Zimmer Persona PCR TKA		Subjects implanted with a Zimmer Persona PCR TKA Receives: Device: Persona PCR TKA
Zimmer Persona PS TKA		Subjects implanted with a Zimmer Persona PS TKA Receives: Device: Persona PS TKA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3 months post-operative
Maximum Flexion, in Degrees, During Deep Knee Bend Activity
Maximum weight-bearing flexion, in degrees, during deep knee bend activity
Measured: 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.
Measured: 3 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202016 May 2022

First posted25 Mar 2020
Study start24 Feb 2020
Primary completion16 May 2022
Study completion16 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04321356
Sponsor's protocol ID: 3187FB WIRB20180745 Extension
Status last verified: Feb 2023
First submitted: 19 Dec 2019
Last updated: 28 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of Competitive PCR and PS Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT04321356
Acronym / sponsor ID: 3187FB WIRB20180745 Extension
Conditions: Knee Osteoarthritis, Total Knee Arthroplasty, Knee
Keywords: Total Knee Arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Collaborators: Smith & Nephew, Inc.
Study start: 24 Feb 2020 (actual)
Primary completion: 16 May 2022 (actual)
Study completion: 16 May 2022 (actual)
First posted: 25 Mar 2020 (actual)
Results: Posted 28 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Stryker Triathlon PCR TKA	–	Device: Triathlon PCR TKASubjects implanted with a Stryker Triathlon PCR TKA
Stryker Triathlon PS TKA	–	Device: Triathlon PS TKASubjects implanted with a Stryker Triathlon PS TKA
Zimmer Persona PCR TKA	–	Device: Persona PCR TKASubjects implanted with a Zimmer Persona PCR TKA
Zimmer Persona PS TKA	–	Device: Persona PS TKASubjects implanted with a Zimmer Persona PS TKA

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (9 listed)

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).

Key exclusion criteria (10 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Triathlon PCR TKATotal Knee Arthroplasty System	Device	Stryker Triathlon PCR TKA
Triathlon PS TKATotal Knee Arthroplasty System	Device	Stryker Triathlon PS TKA
Persona PCR TKATotal Knee Arthroplasty System	Device	Zimmer Persona PCR TKA
Persona PS TKATotal Knee Arthroplasty System	Device	Zimmer Persona PS TKA

Primary outcome

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

Results and safety

Results posted to the registry on 28 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stryker Triathlon PCR TKA	31	31
Stryker Triathlon PS TKA	26	26
Zimmer Persona PCR TKA	29	29
Zimmer Persona PS TKA	14	14

Primary outcome: Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: millimeters

Measure	Stryker Triathlon PCR TKA n = 31	Stryker Triathlon PS TKA n = 26	Zimmer Persona PCR TKA n = 29	Zimmer Persona PS TKA n = 14
Value	4.2 (3.6)	-0.4 (3.4)	-0.5 (2.1)	-3.3 (4.8)

Primary outcome: Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: millimeters

Measure	Stryker Triathlon PCR TKA n = 31	Stryker Triathlon PS TKA n = 26	Zimmer Persona PCR TKA n = 29	Zimmer Persona PS TKA n = 14
Value	0.7 (3.6)	-3.3 (3.5)	0.6 (2.3)	-5.2 (4.8)

Primary outcome: Maximum Flexion, in Degrees, During Deep Knee Bend Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: degrees

Measure	Stryker Triathlon PCR TKA n = 31	Stryker Triathlon PS TKA n = 26	Zimmer Persona PCR TKA n = 29	Zimmer Persona PS TKA n = 14
Value	107 (11)	101 (16)	107 (11)	114 (17)

Primary outcome: Axial Rotation, in Degrees, During Deep Knee Bend Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: degrees

Measure	Stryker Triathlon PCR TKA n = 31	Stryker Triathlon PS TKA n = 26	Zimmer Persona PCR TKA n = 29	Zimmer Persona PS TKA n = 14
Value	4.3 (4.4)	3.6 (3.7)	-1.5 (4.0)	2.8 (4.7)

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stryker Triathlon PCR TKA	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Stryker Triathlon PS TKA	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Zimmer Persona PCR TKA	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Zimmer Persona PS TKA	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Komistek, PhD principal investigator

The University of Tennessee

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by The University of Tennessee, Knoxville at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity (time frame: 3 months post-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.