Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System

Completed

Conditions: Total Knee Arthroplasty
Osteoarthritis

Interventions: Device: DePuy Attune posterior stabilizing fixed bearing knee system

Registration Number: NCT02204748

Lead Sponsor: The University of Tennessee, Knoxville

Brief Summary: A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there is no hypothesis.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

Inclusion Criteria

At least three (3) months post-operative with no other surgical procedures conducted within the past six months
Between 30-80 years of age
Body weight of less than 280 lbs
Must be between 160cm (5'3) and 193cm (6'4) tall
Body Mass Index (BMI) >18.5 and <35
Judged clinically successful with a Knee Society score (KSS) of greater than 80
Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
Will have a DePuy Attune PS TKA
Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in the study

Exclusion Criteria

Pregnant or potentially pregnant females will be excluded from the study

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DePuy Attune PS FB TKA	DePuy Attune posterior stabilizing fixed bearing knee system	Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.

Primary Outcome Measures

Name	Time	Method
Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down	3 months post-operative	Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend	3 months post-operative	Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Femoro-tibial Kinematics: Translation and Lift-off for Gait	3 months post-operative	Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Femoro-tibial Kinematics - Deep Knee Bend	3 months post-operative	Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Femoro-tibial Kinematics - Gait	3 months post-operative	Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Femoro-tibial Kinematics - Ramp Down	3 months post-operative	Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

Secondary Outcome Measures

Name	Time	Method
Max Ground Reaction Force - Deep Knee Bend	3 months post-operative	Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
Max Ground Reaction Force - Ramp Down	3 months post-operative	Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
Max Ground Reaction Force - Gait	3 months post-operative	Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."

Trial Locations

Locations (2): The University of Tennessee
🇺🇸
Knoxville, Tennessee, United States
OrthoCarolina Research Institute
🇺🇸
Charlotte, North Carolina, United States