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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Amputation of Knee
• Intervention / Treatment: Procedure: Through knee amputation; Procedure: Above knee Amputation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mo Adly, Resident; Phone Number: +201553287304; Email: aadly1098@gmail.com
• Study Contact Backup: Name: Ahmed Mu Nagy, Lecturer; Phone Number: 01009887422; Email: ah.mostafa.nagy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Through knee amputation	Procedure: Through knee amputation; Amputation Technique; Procedure: Above knee Amputation; Amputation Technique
Active Comparator: Above knee Amputation	Procedure: Through knee amputation; Amputation Technique; Procedure: Above knee Amputation; Amputation Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing rate	Rates of healing of different amputees	One year
Incidence of infection		One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function of the limb Rehabilitation Quality of life	Incidence of recurrence	Two years
Mortality rate		Tow years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ahmed Mu Nagy, Assiut University

Publications and helpful links

General Publications

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
• Kolossvary E, Farkas K, Karahan O, Golledge J, Schernthaner GH, Karplus T, Bernardo JJ, Marschang S, Abola MT, Heinzmann M, Edmonds M, Catalano M. The importance of socio-economic determinants of health in the care of patients with peripheral artery disease: A narrative review from VAS. Vasc Med. 2023 Jun;28(3):241-253. doi: 10.1177/1358863X231169316. Epub 2023 May 8.
• Panhelleux B, Shalhoub J, Silverman AK, McGregor AH. A review of through-knee amputation. Vascular. 2022 Dec;30(6):1149-1159. doi: 10.1177/17085381211045183. Epub 2021 Nov 29.
• Crane H, Boam G, Carradice D, Vanicek N, Twiddy M, Smith GE. Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations. Cochrane Database Syst Rev. 2021 Dec 14;12(12):CD013839. doi: 10.1002/14651858.CD013839.pub2.
• Howard RR, Chamberlain J, Macpherson AI. Through-knee amputation in peripheral vascular disease. Lancet. 1969 Aug 2;2(7614):240-2. doi: 10.1016/s0140-6736(69)90007-5. No abstract available.
• Cull DL, Taylor SM, Hamontree SE, Langan EM, Snyder BA, Sullivan TM, Youkey JR. A reappraisal of a modified through-knee amputation in patients with peripheral vascular disease. Am J Surg. 2001 Jul;182(1):44-8. doi: 10.1016/s0002-9610(01)00663-8.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Through knee amputation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No