Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- The University of New South Wales
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Visual pain analogue score
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Cameron Handford
Dr Cameron Handford
The University of New South Wales
Eligibility Criteria
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
Outcomes
Primary Outcomes
Visual pain analogue score
Time Frame: 6 months
X-ray analysis of joint alignment
Time Frame: 5-7 year
Using X-rays, the knee was assessed for mechanical and anatomical alignment
range of motion
Time Frame: 5-7 years
visual analogue pain score
Time Frame: 5-7 years
activities of daily living
Time Frame: 5-7 years
Range of motion
Time Frame: 6 weeks
The range of motion of the joint was assessed in both flexion and extension
Activities of Daily Living
Time Frame: 6 weeks
Questionnaire looking at how the intervention impacts of activities of daily living
visual pain analogue score
Time Frame: 12 months