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临床试验/NCT05837182
NCT05837182尚未招募不适用

The Role of Augmented Fixation Techniques in Fragility Fracture Pelvis (FFP)

Assiut University0 个研究点目标入组 30 人开始时间: 2023年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
assess change in functional outcome of augmented fixation techniques in fragility fracture pelvis

研究概览

简要总结

Assessment of the role of augmented fixation of fragility fracture pelvis in improving functional outcome as a primary outcome and improving union and decreasing mortality and complications as secondary outcomes at 6 months and one year follow up.

详细描述

During the process of aging, the quality of bones deteriorates making bones more vulnerable for fractures after minor trauma or from normal daily activities. This poor bone quality together with comorbidities increase healing problems and complications and make fixation more difficult. Moreover, immobilization due to fractures has serious complications especially in the elderly. For all theses, fragility fracture-which is defined by WHO as a fracture that is caused by an injury that would be insufficient to fracture normal bones and is the result of reduced compressive and or torsional strength of bone - these fractures have unique criteria making them a special category with its own concerns. One of these fractures is fragility fracture pelvis (FFP) which is expected to triple between 2005 and 2030. This type of fracture has its huge effect on morbidity and mortality of this vulnerable group of people. Due to its special criteria , a new classification system was developed to classify it known as Rommens classification system. This was followed by many literatures focused on this fracture, its morbidity and mortality, role of surgery, minimal invasive techniques and different augmentation fixation techniques, but they did not reach to a clear algorithm for management and did not clearly identify the role of augmented fixation techniques on different outcomes of this fracture . Fixation augmentation techniques which are defined as surgical techniques aimed at increasing implant stability and used in poor bone quality like in geriatric population. the investigators hypothesis is augmented fixation will improve the functional outcomes of fragility fracture pelvis. These techniques may include percutaneous transsarcal screws fixation, tension band plating, INFIX technique, triangular fixation and cement augmentation techniques.

the investigators will try to answer this question which is "what is the effect of augmented fixation techniques on functional outcomes of fragility fracture pelvis? ''.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above age of sixty years.
  • Fragility fracture pelvis
  • injury severity score below
  • Controlled comorbidities

排除标准

  • Malignancy in bony pelvis.
  • Chronic kidney disease on regular dialysis,
  • Skin lesion at admission like Morel-Lavallée lesion.

结局指标

主要结局

assess change in functional outcome of augmented fixation techniques in fragility fracture pelvis

时间窗: at 6 weeks, 6 months and one year

functional outcome using Majeed score system(0 to 100) with 100 is best outcome

次要结局

  • one year mortality rate(one year)
  • assess change in radiological union and complications(CT at 6 months and one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mokhtar Seleem

Principal Investigator

Assiut University

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