Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures - A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Timed up and go test (TUG)
研究概览
简要总结
The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the "Timed up and go"-test (TUG).
详细描述
HA via various well established approaches is the typical treatment for displaced femoral neck fractures in elderly patients. In the last decade, so called minimal-invasive surgery (MIS) for the implantation of total hip arthroplasty (THA) has become popular and studies have demonstrated that MIS is as safe as conventional approaches. Our hypothesis is that femoral neck fracture patients may especially benefit from MIS. To date, no published data exist comparing a Hueter minimal-invasive anterior (AMIS) with a conventional trans-gluteal Hardinge approach (CLAS) for HA.
Geriatric patients presenting at the University hospital Basel (UHBS) with a femoral neck fracture eligible for HA are randomly assigned to the minimal-invasive or conventional group. In both groups HA will be performed using the same implants. Postoperatively patients will be followed-up continuously until discharge from our hospital (with 7 days as expected average duration of postoperative hospital stay) with a first functional status assessment on day 5. Further follow-up is planned at week 3 and 6, 3 months and one year postoperatively.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 60 years or more, ambulatory with/without walking aids before trauma
- •Femoral neck fracture eligible for hemi-arthroplasty in accordance with the algorithm for femoral neck fracture patients used at the University hospital Basel
- •Informed consent
排除标准
- •Refusal of consent by the patient or legal representatives to participate in the study
- •More than one fracture
- •Suspicion of a pathological fracture in the context of known or unknown malignancy
- •Previous surgery of the proximal femur on the same side
- •Follow-up not possible (Tourist etc.)
结局指标
主要结局
Timed up and go test (TUG)
时间窗: 3 weeks postoperatively +/- 3 days
TUG: Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again (with or without walking aids).
次要结局
- One year mortality(one year)
- Length of hospitalization(duration of the hospital stay, an expected average of 10 days)
- Peri-operative factors(Peri-operative period, i.e. time between admission until day 5 postoperative, expected average period of 5-8 days)
- Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ)(one year)
- Timed up and go test (TUG)(day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days))
- Functional Independence measure (FIM)(preoperative (retrospective assessment), day 5 postoperatively, 3 and 6 weeks postoperatively, 3 months and 1 year postoperatively (apart from measurement on day 5 postoperative each +/- 3 days ))
- Postoperative complications(duration from surgery until 1 year postoperatively)
- Peri-operative delirium(duration from admission to day 3, an expected average period of 3-5 days)