Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02613338

Enrollment

Registered

2015-11-24

Start date

2015-11-30

Completion date

2019-01-31

Last updated

2019-11-12

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 continuation of the study will analyze 30 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.

Interventions

DEVICEDePuy Attune posterior stabilizing fixed bearing knee system

Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.

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

Exclusion criteria

* Pregnant or potentially pregnant females will be excluded from the study.

Design outcomes

Primary

Measure	Time frame	Description
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion	3 months post-operative	Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion	3 months post-operative	Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down
Femoro-tibial Kinematics - Axial Rotation	3 months post-operative	Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.
Femoro-tibial Kinematics - Weight-bearing Flexion	3 months post-operative	Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.

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 activity. was normalized with respect to participant's body weight 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 activity. was normalized with respect to participant's body weight 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 activity was normalized with respect to participant's body weight and has been termed maximum reaction force.

Countries

United States

Participant flow

Participants by arm

Arm	Count
DePuy Attune PS FB Knee System Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.	30
Total	30

Baseline characteristics

Characteristic	DePuy Attune PS FB Knee System	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	23 Participants	—
Age, Categorical Between 18 and 65 years	7 Participants	—
Age, Continuous	68.48 years STANDARD_DEVIATION 5.16	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	30 Participants	—
Sex: Female, Male Female	15 Participants	—
Sex: Female, Male Male	15 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

Femoro-tibial Kinematics - Axial Rotation

Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.