Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-22
Brief Title:
Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function
Sponsor:
Assiut University
Organization:
Assiut University
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?:
None