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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613338
• Other study ID #: 9568FB
• Secondary ID: IIS-13002
• Status: Completed
• Start date: November 2015
• Est. completion date: January 2019

Study information

• Verified date: October 2019
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	Abercrombie Radiology	Knoxville	Tennessee
United States	Dougherty Engineering Building, Room M007	Knoxville	Tennessee
United States	Perkins Hall, The University of Tennessee	Knoxville	Tennessee
United States	Science and Engineering Research Facility, The University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	DePuy Synthes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion	Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down	3 months post-operative
Primary	Femoro-tibial Kinematics - Medial Anterior/Posterior Motion	Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down	3 months post-operative
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.	3 months post-operative
Primary	Femoro-tibial Kinematics - Weight-bearing Flexion	Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.	3 months post-operative
Secondary	Max Ground Reaction Force - Deep Knee Bend	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."	3 months post-operative
Secondary	Max Ground Reaction Force - Gait	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."	3 months post-operative
Secondary	Max Ground Reaction Force - Ramp Down	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."	3 months post-operative