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

Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02204748

Enrollment

Registered

2014-07-30

Start date

2014-11-30

Completion date

2015-08-31

Last updated

2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Total Knee Arthroplasty

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.

Interventions

DEVICEDePuy Attune posterior stabilizing fixed bearing knee system

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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 - 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 - 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.

Secondary

Measure	Time frame	Description
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.
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 - 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
DePuy Attune PS FB TKA Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system	5
Total	5

Baseline characteristics

Characteristic	DePuy Attune PS FB TKA
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	3 Participants
Age, Categorical Between 18 and 65 years	2 Participants
Age, Continuous	66.2 years STANDARD_DEVIATION 8.07
Region of Enrollment United States	5 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 5
serious Total, serious adverse events	0 / 5

Outcome results

Primary

Femoro-tibial Kinematics - Deep Knee Bend

Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.