Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements

Study Overview
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Brief Summary
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This is a randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. Participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. The literature and joint registry of Australia shows that one of the prosthesis may be inferior to the other. Our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Fixed bearing prosthesis
* Device: Mobile bearing prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty Exclusion Criteria: refusal to participate other simultaneous surgery post traumatic osteoarthritis prior open knee surgery
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomised group 1<br>This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis. | Device: Fixed bearing prosthesis<br> <br> |
| Experimental: Randomised group 2<br>This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis. | Device: Mobile bearing prosthesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual pain analogue score | Participants asked to rate their level of pain on a scale | 6 weeks | 
| Range of motion | The range of motion of the joint was assessed in both flexion and extension | 6 weeks | 
| Activities of Daily Living | Questionnaire looking at how the intervention impacts of activities of daily living | 6 weeks | 
| X-ray analysis of joint alignment | Using X-rays, the knee was assessed for mechanical and anatomical alignment | 5-7 year | 
| Visual pain analogue score |  | 6 months | 
| visual pain analogue score |  | 12 months | 
| visual analogue pain score |  | 5-7 years | 
| range of motion |  | 6 months | 
| range of motion |  | 1 year | 
| range of motion |  | 5-7 years | 
| activities of daily living |  | 6 months | 
| activities of daily living |  | 1 year | 
| activities of daily living |  | 5-7 years |