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

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. 2. 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). 3. 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. 4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.

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Key information

Conditions

Knee Prosthesis Knee Arthroplasty

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Porter Adventist Hospital, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Pregnant females.
Patients that do not meet study requirements.

Treatment and study plan

DePuy fixed-bearing Total Condylar III (TC3) TKA

Device

DePuy PFC Rotating Platform TC3 TKA

Device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

DePuy Orthopaedics

Registry information

Official study title

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

Acronym: PFC & TC3

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2013
First posted: Feb 7, 2011
Registry last updated: Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed