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Clinical Trials/NCT02613338
NCT02613338
Completed
N/A

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

The University of Tennessee, Knoxville5 sites in 1 country30 target enrollmentNovember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
The University of Tennessee, Knoxville
Enrollment
30
Locations
5
Primary Endpoint
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
January 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The University of Tennessee, Knoxville
Responsible Party
Principal Investigator
Principal Investigator

Richard Komistek

Fred M. Roddy Professor of Biomedical Engineering

The University of Tennessee, Knoxville

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 3 months post-operative

Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.

Secondary Outcomes

  • Max Ground Reaction Force - Ramp Down(3 months post-operative)
  • Max Ground Reaction Force - Deep Knee Bend(3 months post-operative)
  • Max Ground Reaction Force - Gait(3 months post-operative)

Study Sites (5)

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