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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing rate', 'timeFrame': 'One year', 'description': 'Rates of healing of different amputees'}, {'measure': 'Incidence of infection', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Function of the limb Rehabilitation Quality of life', 'timeFrame': 'Two years', 'description': 'Incidence of recurrence'}, {'measure': 'Mortality rate', 'timeFrame': 'Tow years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amputation of Knee']}, 'referencesModule': {'references': [{'pmid': '18295618', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37154387', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34844469', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34904714', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4184110', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11532414', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Severe peripheral arterial disease with or without comorbid diabetes mellitus accounts for the majority of patients requiring major lower extremity amputations.\n\nThere 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.\n\nWith 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.\n\nCompared 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.\n\nIn 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.\n\nAmong 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critical limb ischemia with sever infection with no role For BKA\n* Acute late or total ischemia SFA with poor\n* popliteal signals and no distal run off\n* Infected Diabetic foot (DF) affecting heel and calf muscle with preserved knee joint\n* Traumatic gangrene\n\nExclusion Criteria:\n\n* Venous gangrene'}, 'identificationModule': {'nctId': 'NCT06365203', 'briefTitle': 'Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function', 'orgStudyIdInfo': {'id': 'Through knee amputation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Through knee amputation', 'description': 'Through knee amputation', 'interventionNames': ['Procedure: Through knee amputation', 'Procedure: Above knee Amputation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Above knee Amputation', 'description': 'Above knee Amputation', 'interventionNames': ['Procedure: Through knee amputation', 'Procedure: Above knee Amputation']}], 'interventions': [{'name': 'Through knee amputation', 'type': 'PROCEDURE', 'description': 'Amputation Technique', 'armGroupLabels': ['Above knee Amputation', 'Through knee amputation']}, {'name': 'Above knee Amputation', 'type': 'PROCEDURE', 'description': 'Amputation Technique', 'armGroupLabels': ['Above knee Amputation', 'Through knee amputation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Mo Adly, Resident', 'role': 'CONTACT', 'email': 'aadly1098@gmail.com', 'phone': '+201553287304'}, {'name': 'Ahmed Mu Nagy, Lecturer', 'role': 'CONTACT', 'email': 'ah.mostafa.nagy@gmail.com', 'phone': '01009887422'}], 'overallOfficials': [{'name': 'Ahmed Mu Nagy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at vascular surgery department at Assiut University', 'investigatorFullName': 'Ahmed Mohammed Adly Omar', 'investigatorAffiliation': 'Assiut University'}}}}