Study of an all polyethylene tibial component
Research type
Research Study
Full title
A prospective study of an all polyethylene tibial component used in total knee arthroplasty surgery
IRAS ID
181031
Contact name
Alistair M Ewen
Contact email
Sponsor organisation
National Waiting Times Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
In this prospective single cohort investigation, outcomes of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) will be determine around 18 months post-operatively.
In the majority of TKA operations, a metal tibial tray is attached to the shin bone (tibia) and a plastic (high density polyethylene) bearing is attached on to it. These ‘metal backed’ tibial components are expensive. A lower cost alternative does away with the high cost metal tray by using a single all polyethylene piece which is attached directly to the shin bone.
Consecutive TKA patients under the care of two consultant orthopaedic surgeons at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Recruitment will continue until 30 participants have had the all polyethylene tibia implanted.
Participants will return for their standard post-operative follow-up appointments (6 weeks and 1 year post-operatively). At the 6 week post-operative appointment they will have a bone mineral density (BMD) scan in addition to a plain radiograph of the whole leg. They will also have an additional appointment at the hospital around 18 months post-operatively specifically for a second BMD scan. Neither of the BMD scans are part of standard care.
The data which will be analysed will be, the results of the bone scans, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative follow-ups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to determine if the all polyethylene tibia has satisfactory outcomes with no adverse effects.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0187
Date of REC Opinion
3 Dec 2015
REC opinion
Further Information Favourable Opinion