Trial Outcomes & Findings for In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA) (NCT NCT04113785)

NCT ID: NCT04113785

Last Updated: 2019-11-15

Results Overview

Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: at least 6 months post-operative
• Results posted on: 2019-11-15

Participant Flow

Participant milestones

Measure	Klassic TKA 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 Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Klassic TKA n=21 Participants 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
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=5 Participants
Age, Categorical >=65 years	NA Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants
Race (NIH/OMB) White	NA Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants

PRIMARY outcome

Timeframe: at least 6 months post-operative

Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.

Outcome measures

Measure

Klassic TKA n=21 Participants 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

Axial Rotation (AR) During Deep Knee Bend

6.6 degrees Standard Deviation 3.2

PRIMARY outcome

Timeframe: at least 6 months post-operative

Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.

Outcome measures

Measure

Klassic TKA n=21 Participants 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

Maximum Weight-bearing Flexion During Deep Knee Bend

111.7 degrees Standard Deviation 13.3

PRIMARY outcome

Timeframe: at least 6 months post-operative

Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.

Outcome measures

Measure

Klassic TKA n=21 Participants 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

Medial Condyle Translations During Deep Knee Bend Activity.

2.5 mm Standard Deviation 2.0

PRIMARY outcome

Timeframe: at least 6 months post-operative

Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.

Outcome measures

Measure

Klassic TKA n=21 Participants 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

Lateral Condyle Translations During Deep Knee Bend Activity

2.5 mm Standard Deviation 2.0

Adverse Events

Klassic TKA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Komistek, Principal Investigator

University of Tennessee

Phone: 8659742093

Email: rkomiste@utk.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place