Osteoarthritis
Conditions
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.
Interventions
DEVICEFixed bearing prosthesis
DEVICEMobile bearing prosthesis
Sponsors
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual pain analogue score | 6 weeks | Participants asked to rate their level of pain on a scale |
| Range of motion | 6 weeks | The range of motion of the joint was assessed in both flexion and extension |
| Activities of Daily Living | 6 weeks | Questionnaire looking at how the intervention impacts of activities of daily living |
| X-ray analysis of joint alignment | 5-7 year | Using X-rays, the knee was assessed for mechanical and anatomical alignment |
| visual pain analogue score | 12 months | — |
| visual analogue pain score | 5-7 years | — |
| range of motion | 6 months | — |
| activities of daily living | 6 months | — |
Countries
Australia
Outcome results
None listed