Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The difference of the level of IL-6 in operated patients.
研究概览
简要总结
Hip fractures are one of the most frequent fractures in older adults. There is still controversy which surgical strategy is the best option for treatment of hip fractures especially trochanteric region fractures. Surgical intervention that follows hip fracture induces biochemical, physiological and fibrinolytic changes that are so-called "second hit phenomenon" which trigger systemic inflammatory response syndrome. The investigators are aiming to study this phenomenon after two different surgical procedures and help surgeons in everyday practice to choose the most suitable surgical treatment for patients with trochanteric region fracture and give the scientific community more evidence which methods is better since there is still controversy.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with trochanteric region fractures AO/OTA 31.A1-31.A2
- •Time from fracture till surgery up to 1 week
- •American Society of Anesthesiologists Classification (ASA) I-III
- •Willing to participate
排除标准
- •Polytrauma patients
- •Open fractures
- •Existing local or systemic infection
- •Pre-existing coagulatory disorder
- •Existing malignancy
- •Corticosteroid use
- •Systemic inflammatory disease
- •Voluntary withdraws of the patient
结局指标
主要结局
The difference of the level of IL-6 in operated patients.
时间窗: 1 hour before and 24 hours after operation
The blood will be collected and after that centrifuged and then stored in -20 grade celsius. The analysis of each sample will be performed no later than 3 months.
次要结局
- The difference of the length of operation(Intra-operatively)
- The difference of the level of CRP in operated patients.(1 hour before and 24 hours after operation. Length of operation, length of incision, blood loss perioperatively. Complication and mortality rate within 1 month after OP)
- The difference of the level of D-dimer(1 hour before and 24 hours after operation)
- The difference of the level of ESR(1 hour before and 24 hours after operation)
- The difference of the level of length of incision(After the wound closure)
- Blood loss(Levels of HB before and after surgery. Also the total volume of blood transfusion.)
- Complications after surgery(Within 1 month after surgery)
- Mortality rate(Within 1 month after surgery)
研究者
Kushtrim Grezda
Principal Investigator, Clinical Research
University Clinical Centre of Kosova