A Prospective Multicenter Cohort Study to Evaluate the Effect of Early Mobilization of Patients After Hip Fracture Fixation on Functional Outcomes in the Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 11
- 主要终点
- Modified Barthel Index
研究概览
简要总结
The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population.
详细描述
The primary objective of this prospective observational cohort study is to assess the difference in functionality between Group I and II (see mobilization regimens for the two groups above) at 6 weeks using the modified Barthel Index in the Chinese population.
The allocation of patients to the two groups will be performed on a clinic level: 50% of patients will be recruited by study sites in Group I (early mobilization). The other 50% of patients will be recruited by study sites in Group II. The sites are carefully selected after evaluating their standard procedures of mobilizing elderly patients after hip fractures. This process is documented using formal site selection questionnaires.
The modified Barthel Index is estimated at 75 points for Group II and at 85 points for Group I.
Patients aged 65 years and older with unstable intertrochanteric fractures (AO 31 A2 or A3) treated with an intramedullary nail will be included in this study.
The study visits will be defined as preoperative, surgery, discharge, 6 (± 2) weeks and 12 (± 2) weeks follow-up (FU) visits. Furthermore, there will be a telephone contact 12 months (± 1 month) postsurgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 and older
- •Diagnosis of an unstable intertrochanteric fractures (AO 31- A2 or A3) treated with an intramedullary nail
- •Ability to walk independently or with a walking aid prior to injury
- •Informed consent obtained, i.e.: Ability of the patient to understand the content of the patient information / Informed Consent Form and signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent
排除标准
- •Severe dementia
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Modified Barthel Index
时间窗: 6 weeks postoperative
Investigator completed score
次要结局
- Mortality(From surgery up to 1 year postoperative)
- Time to achieve partial and full weight bearing(From surgery to 1 year follow-up)
- Quality of life: EuroQoL (EQ-5D)(12 weeks postoperative)
- Modified Barthel Index(12 weeks postoperative)
- Fixation failures(From surgery up to 1 year follow-up)
- Residential status(Baseline to 1 year follow-up)
- Immobilization-related adverse events(From surgery to 1 year follow-up)
- Muscle loss(From surgery up to 1 year follow-up)
- Duration of hospital stay(For the duration of hospital stay, an expected average of 3 weeks)
- Numbers of re-admissions to the hospital(From surgery to 1 year follow-up)
- Any other adverse events(From surgery up to 1 year follow-up)