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NCT02613338 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by The University of Tennessee, Knoxville.

Completed
Registry status
30
Enrollment target

NCT02613338: Completed study, sponsored by The University of Tennessee, Knoxville.

NCT02613338 is a clinical trial that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02613338 has completed, sponsored by The University of Tennessee, Knoxville.

COMPLETED
Registry status
30 participants
Enrollment target

Study 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.

Primary Outcome

Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down

Interventions

  • DEVICE DePuy Attune posterior stabilizing fixed bearing knee system

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-11
Est. Completion 2019-01

What the finished NCT02613338 record still lists

NCT02613338 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which DePuy Attune posterior stabilizing fixed bearing knee system is the first listed.

NCT02613338 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02613338 about?

NCT02613338 is a clinical study titled "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 b...

What is the current status of trial NCT02613338?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2015-11. Estimated completion is 2019-01.

What interventions are being tested in trial NCT02613338?

The interventions under investigation include: DePuy Attune posterior stabilizing fixed bearing knee system (DEVICE).

Who is sponsoring clinical trial NCT02613338?

This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02613338, the US trial registry maintained by the National Library of Medicine. NCT02613338 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.