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Be Part of Research - Trial Details - Biomechanical Assessment of a High Congruency Knee Bearing

Biomechanical Assessment of a High Congruency Knee Bearing

Not Recruiting

Open to: ALL

Age: 35.0 - N/A

Medical Conditions


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The aim of the project is to compare the biomechanics of three different bearing designs used in total knee replacement (TKR) implants. The bearing is the part in the middle of the knee implant that allows the metal tray attached to the shin bone (tibia) to move in relation to the metal part attached to the thigh bone (femur) and is usually made of plastic (high density polyethylene). There will be three different bearing types in the study, which all give different movements. This study will see which bearing is most like a natural knee and so which design gives the best function and feeling to patients with a TKR. 90 TKR patients from the Golden Jubilee National Hospital will be recruited and randomised to receive one of the three study bearings (30 in each group). In addition, a control group of 30 healthy individuals of similar age will be recruited for comparison. Before surgery and at 4 to 8 weeks and 1 year after their operation patients will attend biomechanical assessment sessions at the University of Strathclyde. The control group will attend the assessment session only once. In each of these sessions they will carry out a number of everyday tasks such as walking, moving from sitting to standing and going up and down stairs. These tasks will be measured using motion capture techniques. Reflective markers placed on each participant will be tracked by cameras so that their movements can be recorded. Force plates in the floor will record the forces during the tasks.

Movement and force data will be analysed to see if any differences exist between the groups and show which bearing gives the most natural movement.

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:

Aug 2015 Sep 2019

Publications

"Komaris DS, Tedesco S, O'Flynn B, Govind C, Clarke J, Riches P. Dynamic stability during stair negotiation after total knee arthroplasty. Clin Biomech (Bristol, Avon). 2021 Jul;87:105410. doi: 10.1016/j.clinbiomech.2021.105410. Epub 2021 Jun 10."; "34130036"; "Komaris DS, Govind C, Murphy AJ, Clarke J, Ewen A, Leonard H, Riches P. Implant design affects walking and stair navigation after total knee arthroplasty: a double-blinded randomised controlled trial. J Orthop Surg Res. 2021 Mar 6;16(1):177. doi: 10.1186/s13018-021-02311-x."; "33676526"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Columbus high congruency bearing on a rotating platform tibia.

Intervention Arm Group : Mobile high congruency bearing;

Intervention Type : DEVICE
Intervention Description : Columbus high congruency bearing on a fixed platform tibia.

Intervention Arm Group : Fixed high congruency bearing;

Intervention Type : DEVICE
Intervention Description : Columbus deep dish bearing on a fixed platform tibia.

Intervention Arm Group : Fixed low congruency bearing;



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.

  • Golden Jubilee National Hospital
    Clydebank
    West Dunbartonshire
    G81 4dy


The study is sponsored by Golden Jubilee National Hospital and is in collaboration with University of Strathclyde.





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Read full details for Trial ID: NCT02422251
Last updated 17 July 2019

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