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In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA) (TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113785
Recruitment Status : Completed
First Posted : October 3, 2019
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Hofmann Arthritis Institute
Duke University
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Retrospective
Conditions Total Knee Arthroplasty
Osteo Arthritis Knee
Knee Implant
Knee Injuries
Intervention Device: Klassic Knee System
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Klassic TKA
Hide Arm/Group Description

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Klassic TKA
Hide Arm/Group Description

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years NA [1] 
Between 18 and 65 years NA [1] 
>=65 years NA [1] 
[1]
The study did not collect age information as this was not of interest to the sponsor. Inclusion criteria included knee performance scores and postoperative time.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female NA [1] 
Male NA [1] 
[1]
The study did not collect gender information as this was not of interest to the sponsor. Inclusion criteria included knee performance scores and postoperative time.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native NA [1] 
Asian NA [1] 
Native Hawaiian or Other Pacific Islander NA [1] 
Black or African American NA [1] 
White NA [1] 
More than one race NA [1] 
Unknown or Not Reported NA [1] 
[1]
The study did not collect race information as this was not of interest to the sponsor. Inclusion criteria included knee performance scores and postoperative time.
1.Primary Outcome
Title Axial Rotation (AR) During Deep Knee Bend
Hide Description Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.
Time Frame at least 6 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Klassic TKA
Hide Arm/Group Description:

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: degrees
6.6  (3.2)
2.Primary Outcome
Title Maximum Weight-bearing Flexion During Deep Knee Bend
Hide Description Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.
Time Frame at least 6 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Klassic TKA
Hide Arm/Group Description:

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: degrees
111.7  (13.3)
3.Primary Outcome
Title Medial Condyle Translations During Deep Knee Bend Activity.
Hide Description Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
Time Frame at least 6 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Klassic TKA
Hide Arm/Group Description:

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: mm
2.5  (2.0)
4.Primary Outcome
Title Lateral Condyle Translations During Deep Knee Bend Activity
Hide Description Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
Time Frame at least 6 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Klassic TKA
Hide Arm/Group Description:

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: mm
2.5  (2.0)
Time Frame at least 6 months post-operative
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Klassic TKA
Hide Arm/Group Description

Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.

Klassic Knee System: At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

All-Cause Mortality
Klassic TKA
Affected / at Risk (%)
Total   0/21 (0.00%) 
Hide Serious Adverse Events
Klassic TKA
Affected / at Risk (%)
Total   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Klassic TKA
Affected / at Risk (%)
Total   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Komistek, Principal Investigator
Organization: University of Tennessee
Phone: 8659742093
EMail: rkomiste@utk.edu
Layout table for additonal information
Responsible Party: Richard Komistek, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT04113785    
Other Study ID Numbers: WIRB20182087
First Submitted: October 1, 2019
First Posted: October 3, 2019
Results First Submitted: October 24, 2019
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019