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

The University of Tennessee, Knoxville logo

The University of Tennessee, Knoxville

Status

Completed

Conditions

Osteoarthritis
Total Knee Arthroplasty

Treatments

Device: DePuy Attune posterior stabilizing fixed bearing knee system

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02613338
9568FB
IIS-13002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

DePuy Attune PS FB knee system
Description:
Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system
Treatment:
Device: DePuy Attune posterior stabilizing fixed bearing knee system

Trial documents
1

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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