This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.
Thirty consecutive TKA patients under the care of two orthopaedic consultants 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. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care. The data which will be analysed will be the results of the bone scan, 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 followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Implantation of an all polyethylene tibial component.
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, United Kingdom
Bone mineral density
Measure of peri-prosthetic bone mineral density
Time frame: 18 to 24 months post-operatively
Intra-operative RoM
Range of movement of the knee joint measured by the navigation computer during surgery
Time frame: Intra-operative
Intra-operative alignment
The leg alignment measured by the navigation computer during surgery.
Time frame: Intra-operative
RoM
Active range of motion of the knee joint
Time frame: 1 year
Oxford Knee Score
Clinical outcome measure
Time frame: 1 year
EQ-5D
General health measure
Time frame: 1 year
Patient satisfaction
Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied)
Time frame: 1 year
Leg alignment
Leg alignment measured from long leg x-rays
Time frame: 1 year
Bone condition
Signs of osteolysis from knee x-rays
Time frame: 1 year
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Complications
Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.
Time frame: 1 year
Implant survivorship
Percentage of implants still in situ over time.
Time frame: 18 to 24 months
Surgeon feedback from surgery
Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire.
Time frame: intra-operative
Component position
Migration of the component over time measured from x-rays
Time frame: 1 year
Peri-prosthetic lucency
Radiolucent lines (\>2mm wide) around the component which may indicate component loosening
Time frame: 1 year