Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline
研究概览
简要总结
The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial.
详细描述
The ideal research design to investigate effectiveness of total hip arthroplasty (THA) would be to randomize patients between surgery and (delayed) non-surgery. Such a randomized controlled trial (RCT) is deemed unethical due to the effect size of THA shown in observational studies.
In this study a target trial is specified (a randomized controlled trial between THA and non-THA) and the target trial is emulated using observational data of 2 dutch hospitals participating in the value based health care (VBHC) programme for hip osteoarthritis. The objective of this study is to compare the effect of THA surgery on hip disability and pain between patients that did or did not receive THA surgery during the Covid-19 pandemic. It is hypothesized that THA is effective in restoring hip function and reduction of pain compared to the control group. The effect of THA has not been demonstrated by means of an RCT before. This study can contribute to the available evidence by assessing causal effectiveness of THA by means of RCT target trial emulation.
As a secondary aim, the assumption of pseudo-random group allocation will be assessed. Logistic regression analysis will be used to test whether group allocation is independent of patient characteristics (age, sex, HOOS-PS baseline, NRS baseline, physical therapy before baseline and follow-up time.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on the waiting list for primary THA between 1-4-2020 up until 31-3-2022 in OLVG or Martini hospital.
- •Completed intake questionnaire (HOOS-PS baseline)
- •Indication osteoarthritis of the hip
排除标准
- •Patients that received THA on both sides within follow-up (1-4-2020 and 1-1-2022) will be excluded.
- •Patients with other indications than osteoarthritis of the hip were excluded.
结局指标
主要结局
Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline
时间窗: 3 months
Ranging from 0 (no difficulty) to 100 (extreme difficulty)
次要结局
- Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline(3 months)
研究者
Rudolf Poolman
Prof. dr.
JointResearch