NCT04113785

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

In Vivo Kinematics for Subjects Implanted With Klassic TKA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.

Detailed description

Enrollment will be increased to 24 subjects to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. 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. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off

Conditions

• Total Knee Arthroplasty
• Osteo Arthritis Knee
• Knee Implant
• Knee Injuries

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2018-10-01
• Primary completion: 2018-12-31
• Completion: 2019-06-05
• First posted: 2019-10-03
• Last updated: 2019-11-15
• Results posted: 2019-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study