Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-29 @ 11:42 PM
Study NCT ID:
NCT06365203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: