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

Knee Arthroplasty Clinical Trial

— PFC & TC3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290640
• Other study ID #: Komistek AG 08-19-20
• Secondary ID: R011373360
• Status: Completed
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: October 2019
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroplasty
• Knee Prosthesis

Intervention

Device:
• DePuy fixed-bearing Total Condylar III (TC3) TKA

• DePuy PFC Rotating Platform TC3 TKA

Locations

Country	Name	City	State
United States	Porter Adventist Hospital	Denver	Colorado
United States	Perkins Hall	Knoxville	Tennessee
United States	Science and Engineering Research Facility	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	March 2013
Primary	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.	March 2013