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临床试验/NCT06365203
NCT06365203Unknown不适用

Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function

Assiut University0 个研究点目标入组 60 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Wound healing rate

研究概览

简要总结

The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation

详细描述

Severe peripheral arterial disease with or without comorbid diabetes mellitus accounts for the majority of patients requiring major lower extremity amputations.

There is also an association between major extremity amputation and lower socio-economic status, attributed to lifestyle and comorbidities, living and working conditions, psychosocial factors, and access to affordable healthcare.

With a transfemoral prosthesis, the amputee weight bears through their ischial tuberosity which can cause discomfort when standing or ambulating. These challenges have been associated with greater abandonment of prosthesis use. An often over looked alternative within amputation surgery is through knee amputation (TKA), which currently comprises less than 5% of all major lower extremity amputations.

Compared with AKA, TKA is a less traumatic procedure with little disruption to thigh muscles, articular cartilage, menisci, and bone (especially with Knee Disarticulation), which in turn reduces post-operative infection and formation of bone spurs.

In contrast, AKA can also provide additional problems. Due to a shorter lever length of the residuum, the unilateral transfemoral amputee requires three times more energy to ambulate with a prosthetic limb compared with a unilateral transtibial amputee.

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

性别
All
接受健康志愿者

入选标准

  • Critical limb ischemia with sever infection with no role For BKA
  • Acute late or total ischemia SFA with poor
  • popliteal signals and no distal run off
  • Infected Diabetic foot (DF) affecting heel and calf muscle with preserved knee joint
  • Traumatic gangrene

排除标准

  • Venous gangrene

研究组 & 干预措施

Above knee Amputation

Active Comparator

Above knee Amputation

干预措施: Through knee amputation (Procedure)

Above knee Amputation

Active Comparator

Above knee Amputation

干预措施: Above knee Amputation (Procedure)

Through knee amputation

Active Comparator

Through knee amputation

干预措施: Through knee amputation (Procedure)

Through knee amputation

Active Comparator

Through knee amputation

干预措施: Above knee Amputation (Procedure)

结局指标

主要结局

Wound healing rate

时间窗: One year

Rates of healing of different amputees

Incidence of infection

时间窗: One year

次要结局

  • Function of the limb Rehabilitation Quality of life(Two years)
  • Mortality rate(Tow years)

研究者

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

Ahmed Mohammed Adly Omar

Resident doctor at vascular surgery department at Assiut University

Assiut University

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