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Completed

NCT Number: NCT02103504

DePuy Attune Total Knee Arthroplasty RSA Study

The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion criteria

  • Active or prior infection
  • Medical condition precluding major surgery

Treatment and study plan

DePuy Attune posterior stabilized fixed bearing total knee replacement

Device

Primary outcomes

  1. Implant migration

    Time frame: 2 years

Secondary outcomes

  1. Functional range of motion

    Time frame: 2 years

  2. Self-reported health status

    Time frame: 2 years

    EQ-5D score

  3. Self-reported joint status

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Michael Dunbar

Other

Collaborators

  • Concord Hospital
  • Maisonneuve-Rosemont Hospital

Registry information

Official study title

Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2014
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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