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

Not Applicable

Not yet recruiting

• Conditions: Amputation of Knee
• Interventions: Procedure: Through knee amputation; Procedure: Above knee Amputation

• Registration Number: NCT06365203
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Among vascular surgeons, TKA is similarly rarely performed. Fear of poor wound healing and potential stump breakdown in longer soft tissue flaps needed to cover epicondyles of the distal femur are possible preconceived misconceptions. Historically, outcomes after TKA are acceptable, but scarce vascular literature exists reporting contemporary outcomes of TKA.

Study Timeline

• Study First Submitted: 2024-03-22
• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• Venous gangrene

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Above knee Amputation	Above knee Amputation	Above knee Amputation
Above knee Amputation	Through knee amputation	Above knee Amputation
Through knee amputation	Through knee amputation	Through knee amputation
Through knee amputation	Above knee Amputation	Through knee amputation

Primary Outcome Measures

Name	Time	Method
Incidence of infection	One year
Wound healing rate	One year	Rates of healing of different amputees

Secondary Outcome Measures

Name	Time	Method
Function of the limb Rehabilitation Quality of life	Two years	Incidence of recurrence
Mortality rate	Tow years