Biomechanical Assessment of a High Congruency Knee Bearing
Clinical Investigation of the Functional Outcomes of High Congruency Versus Low Congruency Knee Bearings
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJuly 18, 2019
July 1, 2019
4.1 years
April 13, 2015
July 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Knee kinematics
Knee range of motion during activities of daily living
1 year
Secondary Outcomes (10)
Hip kinematics
1 year
Hip kinetics
1 year
Knee kinetics
1 year
Ankle kinematics
1 year
Ankle kinetics
1 year
- +5 more secondary outcomes
Study Arms (4)
Mobile high congruency bearing
EXPERIMENTALDevice B Braun Columbus total knee system using a rotating platform tibia and high congruency mobile bearing.
Fixed high congruency bearing
EXPERIMENTALDevice B Braun Columbus total knee system using a fixed tibial platform and high congruency bearing.
Fixed low congruency bearing
EXPERIMENTALDevice B Braun Columbus total knee system using a fixed tibial platform and low congruency bearing.
Control
NO INTERVENTIONHealthy control group
Interventions
Columbus high congruency bearing on a rotating platform tibia.
Columbus high congruency bearing on a fixed platform tibia.
Eligibility Criteria
You may qualify if:
- Primary unilateral total knee replacement
- Suitable to have any one of the three test bearings
- Over 35 years of age
- Willing to take part
- From one of the following NHS Scotland Health Boards: Ayrshire \& Arran, Forth Valley, Greater Glasgow \& Clyde, Highland, Lanarkshire or Lothian
- Able to return for follow up sessions
You may not qualify if:
- Previous hip or knee replacement procedure if carried out in the previous twelve months
- Unable to give written consent
- Unable to attend the movement analysis sessions
- Journey time from home to the university in excess of two hours
- Previous ankle surgery
- Any past neurologic history e.g. stroke, Charcot-Marie-Tooth disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Golden Jubilee National Hospitallead
- University of Strathclydecollaborator
Study Sites (1)
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, G81 4dy, United Kingdom
Related Publications (2)
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). 2021 Jul;87:105410. doi: 10.1016/j.clinbiomech.2021.105410. Epub 2021 Jun 10.
PMID: 34130036DERIVEDKomaris 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.
PMID: 33676526DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic Picard, MD
National Waiting Times Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 21, 2015
Study Start
August 1, 2015
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
July 18, 2019
Record last verified: 2019-07