NCT06365203

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

March 22, 2024

Last Update Submit

April 12, 2024

Conditions

Amputation of Knee

Outcome Measures

Primary Outcomes (2)

  • Wound healing rate

    Rates of healing of different amputees

    One year

  • Incidence of infection

    One year

Secondary Outcomes (2)

  • Function of the limb Rehabilitation Quality of life

    Two years

  • Mortality rate

    Tow years

Study Arms (2)

Through knee amputation

ACTIVE COMPARATOR

Through knee amputation

Procedure: Through knee amputationProcedure: Above knee Amputation

Above knee Amputation

ACTIVE COMPARATOR

Above knee Amputation

Procedure: Through knee amputationProcedure: Above knee Amputation

Interventions

Through knee amputationPROCEDURE

Amputation Technique

Above knee AmputationThrough knee amputation
Above knee AmputationPROCEDURE

Amputation Technique

Above knee AmputationThrough knee amputation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Venous gangrene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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: 18295618BACKGROUND

  • 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: 37154387BACKGROUND

  • 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: 34844469BACKGROUND

  • 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: 34904714BACKGROUND

  • 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: 4184110BACKGROUND

  • 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.

    PMID: 11532414BACKGROUND

Study Officials

  • Ahmed Mu Nagy

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Mo Adly, Resident

CONTACT

+201553287304aadly1098@gmail.com

Ahmed Mu Nagy, Lecturer

CONTACT

01009887422ah.mostafa.nagy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at vascular surgery department at Assiut University

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 15, 2024

Study Start

April 1, 2024

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

April 15, 2024

Record last verified: 2024-04