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

Completed

• Conditions: Total Knee Arthroplasty; Osteoarthritis
• Interventions: Device: DePuy Attune posterior stabilizing fixed bearing knee system

• Registration Number: NCT02613338
• Lead Sponsor: The University of Tennessee, Knoxville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Results First Submitted: 2019-09-23
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Results First Posted: 2019-11-12
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DePuy Attune PS FB knee system	DePuy Attune posterior stabilizing fixed bearing knee system	Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system

Primary Outcome Measures

Name	Time	Method
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 - 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 - 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 Outcome Measures

Name	Time	Method
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."
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."

Trial Locations

Locations (5)

Science and Engineering Research Facility, The University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Abercrombie Radiology; 🇺🇸 Knoxville, Tennessee, United States

Perkins Hall, The University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Dougherty Engineering Building, Room M007; 🇺🇸 Knoxville, Tennessee, United States

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States