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N/A N=30

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

Total Knee Arthroplasty · Osteoarthritis

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion — -5.81; -0.1; 0.58 mm

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
DePuy Attune posterior stabilizing fixed bearing knee system (Device)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
The University of Tennessee, Knoxville
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion
-5.81; -0.1; 0.58
PRIMARY
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion
-1.81; -0.07; -0.14
PRIMARY
Femoro-tibial Kinematics - Axial Rotation
5.4; 0.17; 0.88
PRIMARY
Femoro-tibial Kinematics - Weight-bearing Flexion
110.27; 28.5; 33.8
SECONDARY
Max Ground Reaction Force - Deep Knee Bend
0.83
SECONDARY
Max Ground Reaction Force - Gait
1.09
SECONDARY
Max Ground Reaction Force - Ramp Down
1.06

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02613338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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