Biomechanical Assessment of a High Congruency Knee Bearing
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|ClinicalTrials.gov Identifier: NCT02422251|
Recruitment Status : Unknown
Verified July 2019 by Golden Jubilee National Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : July 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Replacement||Device: Mobile high congruency bearing (Columbus) Device: Fixed high congruency bearing (Columbus)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical Investigation of the Functional Outcomes of High Congruency Versus Low Congruency Knee Bearings|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Mobile high congruency bearing
Device B Braun Columbus total knee system using a rotating platform tibia and high congruency mobile bearing.
Device: Mobile high congruency bearing (Columbus)
Columbus high congruency bearing on a rotating platform tibia.
Experimental: Fixed high congruency bearing
Device B Braun Columbus total knee system using a fixed tibial platform and high congruency bearing.
Device: Fixed high congruency bearing (Columbus)
Columbus high congruency bearing on a fixed platform tibia.
Experimental: Fixed low congruency bearing
Device B Braun Columbus total knee system using a fixed tibial platform and low congruency bearing.
Device: Fixed high congruency bearing (Columbus)
Columbus deep dish bearing on a fixed platform tibia.
No Intervention: Control
Healthy control group
- Knee kinematics [ Time Frame: 1 year ]Knee range of motion during activities of daily living
- Hip kinematics [ Time Frame: 1 year ]Hip range of motion during activities of daily living
- Hip kinetics [ Time Frame: 1 year ]Hip loading during activities of daily living
- Knee kinetics [ Time Frame: 1 year ]Knee loading during activities of daily living
- Ankle kinematics [ Time Frame: 1 year ]Ankle range of motion during activities of daily living
- Ankle kinetics [ Time Frame: 1 year ]Ankle loading during activities of daily living
- EQ-5D [ Time Frame: 1 year ]EQ-5D health questionnaire score
- Oxford Knee Score [ Time Frame: 1 year ]Oxford Knee Score questionnaire score
- Knee alignment [ Time Frame: 1 year ]Frontal plane alignment of the knee
- Patient satisfaction [ Time Frame: 1 year ]Score of patients' satisfaction with the implant
- Complications [ Time Frame: 1 year ]Evidence of any complication related to the surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422251
|Golden Jubilee National Hospital|
|Clydebank, West Dunbartonshire, United Kingdom, G81 4dy|
|Principal Investigator:||Frederic Picard, MD||National Waiting Times Centre|