Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Visual pain analogue score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty
排除标准
- •refusal to participate
- •other simultaneous surgery
- •post traumatic osteoarthritis
- •prior open knee surgery
结局指标
主要结局
Visual pain analogue score
时间窗: 6 months
X-ray analysis of joint alignment
时间窗: 5-7 year
Using X-rays, the knee was assessed for mechanical and anatomical alignment
range of motion
时间窗: 5-7 years
visual analogue pain score
时间窗: 5-7 years
activities of daily living
时间窗: 5-7 years
Range of motion
时间窗: 6 weeks
The range of motion of the joint was assessed in both flexion and extension
Activities of Daily Living
时间窗: 6 weeks
Questionnaire looking at how the intervention impacts of activities of daily living
visual pain analogue score
时间窗: 12 months
次要结局
未报告次要终点
研究者
Cameron Handford
Dr Cameron Handford
The University of New South Wales