Study of an All Polyethylene Tibial Component

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery

Conditions
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Knee Replacement

Intervention / Treatment
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* Device: All-polyethylene tibia (Aesculap AG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral TKA Aged 70 year or older BMI < 37.5 Suitable to receive the study implant Exclusion Criteria: Revision of existing knee replacement Previous lower limb replacement Proximal tibial bone defects Diagnosed osteopenia or osteoporosis Unable to give informed consent Unwilling to take part Unable to return to the Golden Jubilee National Hospital for followup appointments

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All-poly<br>Knee arthroplasty with all-polyethylene tibia | Device: All-polyethylene tibia (Aesculap AG)<br>* Implantation of an all polyethylene tibial component.<br>* Other names: NN1230-NN1233, NN1240-NN1243, NN1250-NN1253;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Measure of peri-prosthetic bone mineral density | 18 to 24 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative RoM | Range of movement of the knee joint measured by the navigation computer during surgery | Intra-operative | 
| Intra-operative alignment | The leg alignment measured by the navigation computer during surgery. | Intra-operative | 
| RoM | Active range of motion of the knee joint | 1 year | 
| Oxford Knee Score | Clinical outcome measure | 1 year | 
| EQ-5D | General health measure | 1 year | 
| Patient satisfaction | Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied) | 1 year | 
| Leg alignment | Leg alignment measured from long leg x-rays | 1 year | 
| Bone condition | Signs of osteolysis from knee x-rays | 1 year | 
| Complications | Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening. | 1 year | 
| Implant survivorship | Percentage of implants still in situ over time. | 18 to 24 months | 
| Surgeon feedback from surgery | Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire. | intra-operative | 
| Component position | Migration of the component over time measured from x-rays | 1 year | 
| Peri-prosthetic lucency | Radiolucent lines (>2mm wide) around the component which may indicate component loosening | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee replacement, Knee arthroplasty, All-polyethylene tibia, Bone density