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Be Part of Research - Trial Details - Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
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Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System

Completed

Open to: ALL

Age: 22.0 - 80.0

Harlow Middlesborough Guildford Llandough Dunfermline York

Medical Conditions

Osteoarthritis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset.

The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2012 Mar 2018

Publications

"Hamilton WG, Brenkel IJ, Barnett SL, Allen PW, Dwyer KA, Lesko JP, Kantor SR, Clatworthy MG. Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study. J Am Acad Orthop Surg Glob Res Rev. 2021 Dec 15;5(12):e21.00136. doi: 10.5435/JAAOSGlobal-D-21-00136."; "34908561"

OBSERVATIONAL

Intervention Type : DEVICE
Intervention Description : Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).

Intervention Arm Group : CR FB;CR RP;PS FB;PS RP;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Princess Alexandra Hospital
    Harlow
    CM20 1QX
  • James Cook University Hospital
    Middlesborough
    Ts4 3Bw
  • The Royal Surrey County Hospital
    Guildford
    Surrey
    GU2 7XX
  • University Hospital Llandough
    Llandough
    CF64 2XX
  • Queen Margaret Hospital
    Dunfermline
    Fife
    KY12 OSU
  • Clifton Park NHS Treatment Centre
    York
    YO30 5RA


The study is sponsored by DePuy Orthopaedics




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Read full details for Trial ID: NCT01746524
Last updated 09 April 2019

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