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

Completed

• Conditions: Knee Prosthesis; Knee Arthroplasty
• Interventions: Device: DePuy fixed-bearing Total Condylar III (TC3) TKA; Device: DePuy PFC Rotating Platform TC3 TKA

• Registration Number: NCT01290640
• Lead Sponsor: The University of Tennessee, Knoxville

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-07
• Primary Completion: 2011-09
• Study Completion: 2013-02
• Results First Submitted: 2013-03-18
• Results First Submitted QC: 2014-01-21
• Results First Posted: 2014-03-07
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Patients must be at least three months post-operative.
2. Potential subjects will have a body weight of less than 250 lbs.
3. Candidates must have had a HSS score >90 post-operatively.
4. Patients must have passive flexion of at least 100.
5. 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.
6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion Criteria

1. Pregnant females.
2. Patients that do not meet study requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TC3 TKA	DePuy fixed-bearing Total Condylar III (TC3) TKA	Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
PFC RP TC3 TKA	DePuy PFC Rotating Platform TC3 TKA	Subjects implanted with a DePuy PFC Rotating Platform TC3 TKA

Primary Outcome Measures

Name	Time	Method
In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.	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.	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.

Trial Locations

Locations (3)

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Perkins Hall; 🇺🇸 Knoxville, Tennessee, United States

Science and Engineering Research Facility; 🇺🇸 Knoxville, Tennessee, United States