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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Amputation of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Through knee amputation

Group Type ACTIVE_COMPARATOR

Through knee amputation

Intervention Type PROCEDURE

Amputation Technique

Above knee Amputation

Intervention Type PROCEDURE

Amputation Technique

Above knee Amputation

Group Type ACTIVE_COMPARATOR

Through knee amputation

Intervention Type PROCEDURE

Amputation Technique

Above knee Amputation

Intervention Type PROCEDURE

Amputation Technique

Interventions

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Through knee amputation

Amputation Technique

Intervention Type PROCEDURE

Above knee Amputation

Amputation Technique

Intervention Type PROCEDURE

Eligibility Criteria

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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