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

Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Total Knee Arthroplasty
• Intervention / Treatment: Device: DePuy Attune posterior stabilizing fixed bearing knee system

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • The University of Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas Fehring of OrthoCarolina, PA in Charlotte, NC.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: DePuy Attune posterior stabilizing fixed bearing knee system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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."	3 months post-operative
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 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."	3 months post-operative
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 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."	3 months post-operative

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: DePuy Orthopaedics
• Investigators: Principal Investigator: Adrija Sharma, Ph. D., University of Tennessee; Principal Investigator: William R Hamel, Ph. D., University of Tennessee

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 13002; R011373503 (Other Identifier: University of Tennessee)