跳至主要内容
临床试验/NCT05225753
NCT05225753已完成不适用

Post-operative Anemia in Lateral Fragility Fractures of the Femur. A Prospective Observational Study in Three Different Intramedullary Nails

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Change in hemoglobin serum value

研究概览

简要总结

It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients treated by Proximal Femoral Nail Antirotation Synthes).

One independent observer performed seven biochemical evaluations (hemoglobin serum value) from admission to patient discharge. Surgical time and Blood transfusions number were reported for each partecipant.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • femur fractures type 31-A1, A2, A3 (Muller ME, Nazarian S, Kock P et al.);
  • age more than 65 years;

排除标准

  • patients with neurological diseases;
  • finding of anemia before surgery;

结局指标

主要结局

Change in hemoglobin serum value

时间窗: Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)

Post-operative anemia was quantified using the hemoglobin serum value ranging between more than 10 g/dl (no post-operative anemia) and less than 10 g/dl (post-operative anemia).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验