CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
DePuy Attune posterior stabilizing fixed bearing knee systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02613338
NCT02613338N/ACompleted

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

The University of Tennessee, Knoxville·observational·Posted Nov 24, 2015·Updated Nov 12, 2019

In Brief

An observational study evaluating DePuy Attune posterior stabilizing fixed bearing knee system for Total Knee Arthroplasty and Osteoarthritis. Completed, enrolled 30 participants across 5 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDePuy Synthes

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 24, 2015
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2018
Study CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.6 years ago

Interventions

DePuy Attune posterior stabilizing fixed bearing knee systemdevice

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