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

A

Assiut University

Status

Not yet enrolling

Conditions

Amputation of Knee

Treatments

Procedure: Above knee Amputation
Procedure: Through knee amputation

Study type

Interventional

Funder types

Other

Identifiers

NCT06365203
Through knee amputation

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Through knee amputation
Active Comparator group
Description:
Through knee amputation
Treatment:
Procedure: Through knee amputation
Procedure: Above knee Amputation
Above knee Amputation
Active Comparator group
Description:
Above knee Amputation
Treatment:
Procedure: Through knee amputation
Procedure: Above knee Amputation

Trial contacts and locations

0

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Central trial contact

Ahmed Mo Adly, Resident; Ahmed Mu Nagy, Lecturer

Data sourced from clinicaltrials.gov

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