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

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.

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): 30

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Perkins Hall, The University of Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Science and Engineering Research Facility, The University of Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Dougherty Engineering Building, Room M007
    • Knoxville, Tennessee, United States, 37909
      • Abercrombie Radiology

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

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

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

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 knee system; Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 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 activity was normalized with respect to participant's body weight 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 activity. was normalized with respect to participant's body weight 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 activity. was normalized with respect to participant's body weight and has been termed "maximum reaction force."	3 months post-operative

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: DePuy Synthes
• 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 (Actual): November 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 20, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: October 23, 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: 9568FB; IIS-13002 (Other Grant/Funding Number: DePuy Synthes)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.