Knee ProsthesisPFC & TC3NCT01290640

Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis

An observational study of Knee Prosthesis and Knee Arthroplasty, run by The University of Tennessee, Knoxville at 3 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 objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Knee Prosthesis, Knee Arthroplasty
What is being tested?: DePuy fixed-bearing Total Condylar III (TC3) TKA and DePuy PFC Rotating Platform TC3 TKA
Type of treatment: Medical device
How many people: 22 participants
Where: 3 sitesUnited States
Study dates: Feb 2011to Feb 2013
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 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects requiring total knee arthroplasty

Who may be able to join

Patients must be at least three months post-operative.
Potential subjects will have a body weight of less than 250 lbs.
Candidates must have had a HSS score >90 post-operatively.
Patients must have passive flexion of at least 100.
All potential subjects will have a Press Fit Condylar (PFC) Rotating Platform Total Condylar III Prosthesis (Depuy Orthopaedics, Warsaw, IN) or fixed-bearing Total Condylar III Prosthesis.
Must be willing to sign both Informed Consent and HIPAA forms.

Who cannot join

Pregnant females.
Patients that do not meet study requirements.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Porter Adventist Hospital
Denver, Colorado, 80210
Perkins Hall
Knoxville, Tennessee, 37996
Science and Engineering Research Facility
Knoxville, Tennessee, 37996

Other trials in United States

About this study

Official title: In Vivo Comparison of Kinematics for Subjects Implanted With a Press Fit Condylar Sigma Rotating Platform or Fixed Bearing Total Condylar III Prothesis

The objectives of this study are four-fold:

To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient.
To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise).
To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types.
To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.

Conditions: Knee Prosthesis, Knee Arthroplasty
Being tested: DePuy fixed-bearing Total Condylar III (TC3) TKA, DePuy PFC Rotating Platform TC3 TKA

What participants receive

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

DePuy fixed-bearing Total Condylar III (TC3) TKADevice
DePuy PFC Rotating Platform TC3 TKADevice

Study groups in NCT01290640
Study group	Role	What they receive
TC3 TKA		Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA Receives: Device: DePuy fixed-bearing Total Condylar III (TC3) TKA
PFC RP TC3 TKA		Subjects implanted with a DePuy PFC Rotating Platform TC3 TKA Receives: Device: DePuy PFC Rotating Platform TC3 TKA

What is being measured

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

In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.
Measured: March 2013
In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation
The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative.
Measured: March 2013

Timeline

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

Feb 2011Feb 2013

First posted7 Feb 2011 (estimated)
Study startFeb 2011
Primary completionSep 2011
Study completionFeb 2013

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 ProsthesisStudies 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: Case-control
Time perspective: Retrospective
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01290640
Sponsor's protocol ID: Komistek AG 08-19-20
Other IDs: R011373360
Acronym: PFC & TC3
Status last verified: Oct 2019
First submitted: 3 Feb 2011
Last updated: 21 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Prosthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Comparison of Kinematics for Subjects Implanted With a Press Fit Condylar Sigma Rotating Platform or Fixed Bearing Total Condylar III Prothesis
ClinicalTrials.gov ID: NCT01290640
Acronym / sponsor ID: PFC & TC3 / Komistek AG 08-19-20
Conditions: Knee Prosthesis, Knee Arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Collaborators: DePuy Orthopaedics
Study start: Feb 2011
Primary completion: Sep 2011 (actual)
Study completion: Feb 2013 (actual)
First posted: 7 Feb 2011 (estimated)
Results: Posted 7 Mar 2014

Clinical summary

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

The objectives of this study are four-fold:

To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient.
To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise).
To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types.
To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
TC3 TKA	–	Device: DePuy fixed-bearing Total Condylar III (TC3) TKASubjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
PFC RP TC3 TKA	–	Device: DePuy PFC Rotating Platform TC3 TKASubjects implanted with a DePuy PFC Rotating Platform TC3 TKA

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects requiring total knee arthroplasty

Key inclusion criteria (6 listed)

Patients must be at least three months post-operative.
Potential subjects will have a body weight of less than 250 lbs.
Candidates must have had a HSS score >90 post-operatively.
Patients must have passive flexion of at least 100.
All potential subjects will have a Press Fit Condylar (PFC) Rotating Platform Total Condylar III Prosthesis (Depuy Orthopaedics, Warsaw, IN) or fixed-bearing Total Condylar III Prosthesis.

Key exclusion criteria (2 listed)

Pregnant females.
Patients that do not meet study requirements.

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
DePuy fixed-bearing Total Condylar III (TC3) TKA	Device	TC3 TKA
DePuy PFC Rotating Platform TC3 TKA	Device	PFC RP TC3 TKA

Primary outcome

In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
Time frame: March 2013
The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.
In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
Time frame: March 2013
Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative.

Results and safety

Results posted to the registry on 7 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Implanted With a DePuy Fixed-bearing Total Condylar I	12	12
Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA	10	10

Primary outcome: In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.

Time frame: March 2013. Mean (Standard Deviation). Unit: mm

Measure	Subjects With DePuy PFC Rotating Platform TC3 TKA n = 10	Subjects With DePuy PFC Fixed Bearing TC3 TKA n = 12
Lateral Anterior Posterior Deep Knee Bend	-3.51 (4.73)	-2.52 (1.92)
Medial Anterior Posterior Deep Knee Bend	-1.68 (2.15)	-1.40 (1.43)
Lateral Anterior Posterior Chair Rise	-10.31 (3.23)	2.89 (3.64)
Medial Anterior Posterior Chair Rise	-0.76 (3.95)	1.02 (2.95)
Lateral Anterior Posterior Gait	-0.88 (2.02)	-1.3 (1.8)
Medial Anterior Posterior Gait	.70 (2.51)	-1.2 (1.5)
Lateral Anterior Posterior Stair Descent	-8.18 (2.08)	-1.92 (2.46)
Medial Anterior Posterior Stair Descent	-1.96 (3.22)	-1.71 (1.80)

Population analysed: Per protocol.

Primary outcome: In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.

Time frame: March 2013. Mean (Standard Deviation). Unit: degrees

Measure	Subjects With DePuy PFC Rotating Platform TC3 TKA n = 10	Subjects With DePuy PFC Fixed Bearing TC3 TKA n = 12
Axial Rotation Deep Knee Bend	8.35 (8.94)	1.99 (4.00)
Axial Rotation Chair Rise	12.22 (8.29)	-2.42 (5.03)
Axial Rotation Gait	6.66 (6.37)	.13 (2.18)
Axial Rotation Stair Descent	8.16 (5.56)	.24 (4.17)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA	0 of 10 (0%)	0 of 10 (0%)	Not reported
Subjects Implanted With a DePuy Fixed-bearing Total Condylar I	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): No limitations were encountered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Active, not recruiting
Survivorship of Attune Primary Total Knee Prosthesis
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Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
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Enrolling by invitation
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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 D. Komistek, Ph D principal investigator

The University of Tennessee

Douglas Dennis, MD principal investigator

Colorado Joint Replacement, Porter Adventist Hosp

3 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 Prosthesis and Knee Arthroplasty, run by The University of Tennessee, Knoxville at 3 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 6 inclusion and 2 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 7 Mar 2014). 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?

In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. (time frame: March 2013). The study lists 2 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 NCT01290640.

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 21 Oct 2019.