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Microvascular Partial Toe Transfer

Primary Purpose

Amputation, Traumatic, Hand Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
microvascular partial toe transfer
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amputation, Traumatic

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient from 18-50 years old
  • one or more finger amputations
  • Minimum follow-up period of 6 months

Exclusion Criteria:

  • patients whose loss was due to congenital anomaly.
  • Patients who did not have a minimum follow-up period of six months .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Traumatic amputations of the digits

    Arm Description

    we will perform microvascular partial toe transfer for patients with traumatic amputations of one or more digits

    Outcomes

    Primary Outcome Measures

    short-term functional outcome
    Using DASH (The Disabilities of the Arm, Shoulder and Hand) score Reference for Score: Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG) Am J Ind Med. 1996 Jun;29(6):602-8. Erratum in: Am J Ind Med 1996 Sep;30(3):372. The Institute for Work & Health are the copyright owners of the DASH and QuickDASH Outcome Measures (http://www.dash.iwh.on.ca/)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2019
    Last Updated
    December 6, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04192084
    Brief Title
    Microvascular Partial Toe Transfer
    Official Title
    Microvascular Partial Toe Transfer for Reconstruction of Traumatic Amputations of the Digits
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits
    Detailed Description
    Microsurgical toe transfer has become a gold standard option for amputated digit reconstruction. It can be used to correct almost any thumb defect. However, for optimal functional and esthetic results, proper initial care, preoperative planning, proper selection of suitable techniques, adjunct or secondary procedures and proper, postoperative rehabilitation are important. The transfer of a toe to replace an amputated thumb represents one of the first applications of microsurgical techniques, yet to this day remains an epitome of reconstructive surgery, restoring critical function and form to the hand-injured patient. While techniques have greatly evolved to permit the treatment of multiple finger amputations, dystrophic nails and pulps, and traumatized or arthritic joint, the amputated thumb retains its status among the most indubitable indications for toe transfer. Microsurgical techniques have been refined to such a degree that almost any ablative deformity of the thumb could be corrected with some form of toe transfer. The question, therefore, is not if a defect could be reconstructed, but whether the patient is willing to undergo reconstruction. The concepts of "adequate function" and "optimal function" are therefore of central importance when discussing treatment options with a patient. Obviously, these parameters will be different for each patient depending upon his/her vocation, avocations, and desires. For many people, adequate function might be expected with an amputation that retains some length of the proximal phalanx (assuming sufficient soft tissue coverage is present or can be provided). However, for patients who require full length of their thumb, or who desire optimal rather than adequate function, toe transfer should be considered. At present, the decision to use a particular toe transfer technique is mostly based on the surgeon's preference and training. The current data are inadequate to make any comments with regards to donor site morbidity. Till such data are available, an evidence-based recommendation for the superiority of a specific type of toe-to-thumb transfer cannot be made. We hypothesis that partial toe transfer provides the best aesthetic and functional reconstruction and the least donor site morbidity amongst all other types of transfers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amputation, Traumatic, Hand Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Traumatic amputations of the digits
    Arm Type
    Experimental
    Arm Description
    we will perform microvascular partial toe transfer for patients with traumatic amputations of one or more digits
    Intervention Type
    Procedure
    Intervention Name(s)
    microvascular partial toe transfer
    Intervention Description
    we will perform microvascular partial toe transfer for patients with traumatic amputation of one or more digits
    Primary Outcome Measure Information:
    Title
    short-term functional outcome
    Description
    Using DASH (The Disabilities of the Arm, Shoulder and Hand) score Reference for Score: Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG) Am J Ind Med. 1996 Jun;29(6):602-8. Erratum in: Am J Ind Med 1996 Sep;30(3):372. The Institute for Work & Health are the copyright owners of the DASH and QuickDASH Outcome Measures (http://www.dash.iwh.on.ca/)
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient from 18-50 years old one or more finger amputations Minimum follow-up period of 6 months Exclusion Criteria: patients whose loss was due to congenital anomaly. Patients who did not have a minimum follow-up period of six months .

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    4959061
    Citation
    Buncke HJ Jr, Buncke CM, Schulz WP. Immediate Nicoladoni procedure in the Rhesus monkey, or hallux-to-hand transplantation, utilising microminiature vascular anastomoses. Br J Plast Surg. 1966 Oct;19(4):332-7. doi: 10.1016/s0007-1226(66)80075-9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    5371970
    Citation
    Cobbett JR. Free digital transfer. Report of a case of transfer of a great toe to replace an amputated thumb. J Bone Joint Surg Br. 1969 Nov;51(4):677-9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    3340671
    Citation
    Wei FC, Chen HC, Chuang CC, Noordhoff MS. Simultaneous multiple toe transfers in hand reconstruction. Plast Reconstr Surg. 1988 Mar;81(3):366-77. doi: 10.1097/00006534-198803000-00009.
    Results Reference
    background
    PubMed Identifier
    10541171
    Citation
    Wei FC, Lutz BS, Cheng SL, Chuang DC. Reconstruction of bilateral metacarpal hands with multiple-toe transplantations. Plast Reconstr Surg. 1999 Nov;104(6):1698-704. doi: 10.1097/00006534-199911000-00013.
    Results Reference
    background
    PubMed Identifier
    3351225
    Citation
    Koshima I, Soeda S, Takase T, Yamasaki M. Free vascularized nail grafts. J Hand Surg Am. 1988 Jan;13(1):29-32. doi: 10.1016/0363-5023(88)90194-3.
    Results Reference
    background
    PubMed Identifier
    4052709
    Citation
    Logan A, Elliot D, Foucher G. Free toe pulp transfer to restore traumatic digital pulp loss. Br J Plast Surg. 1985 Oct;38(4):497-500. doi: 10.1016/0007-1226(85)90007-4.
    Results Reference
    background
    PubMed Identifier
    1924570
    Citation
    Wei FC, Chen HC, Chuang DC, Chen S, Noordhoff MS. Second toe wrap-around flap. Plast Reconstr Surg. 1991 Nov;88(5):837-43. doi: 10.1097/00006534-199111000-00016.
    Results Reference
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    PubMed Identifier
    8942916
    Citation
    Chen SH, Wei FC, Chen HC, Hentz VR, Chuang DC, Yeh MC. Vascularized toe joint transfer to the hand. Plast Reconstr Surg. 1996 Dec;98(7):1275-84. doi: 10.1097/00006534-199612000-00025.
    Results Reference
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    PubMed Identifier
    12479617
    Citation
    Lutz BS, Wei FC. Basic principles on toe-to-hand transplantation. Chang Gung Med J. 2002 Sep;25(9):568-76.
    Results Reference
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    PubMed Identifier
    22942845
    Citation
    Lin PY, Sebastin SJ, Ono S, Bellfi LT, Chang KW, Chung KC. A systematic review of outcomes of toe-to-thumb transfers for isolated traumatic thumb amputation. Hand (N Y). 2011 Sep;6(3):235-43. doi: 10.1007/s11552-011-9340-x. Epub 2011 May 26.
    Results Reference
    background
    PubMed Identifier
    9858192
    Citation
    Wei FC. Tissue preservation in hand injury: the first step to toe-to-hand transplantation. Plast Reconstr Surg. 1998 Dec;102(7):2497-501. doi: 10.1097/00006534-199812000-00039.
    Results Reference
    background
    PubMed Identifier
    7574290
    Citation
    Yim KK, Wei FC. Intraosseous wiring in toe-to-hand transplantation. Ann Plast Surg. 1995 Jul;35(1):66-9. doi: 10.1097/00000637-199507000-00013.
    Results Reference
    background
    PubMed Identifier
    6386954
    Citation
    Wilson CS, Buncke HJ, Alpert BS, Gordon L. Composite metacarpophalangeal joint reconstruction in great toe-to-hand free tissue transfers. J Hand Surg Am. 1984 Sep;9(5):645-9. doi: 10.1016/s0363-5023(84)80004-0.
    Results Reference
    background
    PubMed Identifier
    7000885
    Citation
    Morrison WA, O'Brien BM, MacLeod AM. Thumb reconstruction with a free neurovascular wrap-around flap from the big toe. J Hand Surg Am. 1980 Nov;5(6):575-83. doi: 10.1016/s0363-5023(80)80110-9.
    Results Reference
    background
    PubMed Identifier
    8700986
    Citation
    Wei FC, Chen HC, Chuang DC, Jeng SF, Lin CH. Aesthetic refinements in toe-to-hand transfer surgery. Plast Reconstr Surg. 1996 Sep;98(3):485-90. doi: 10.1097/00006534-199609000-00019.
    Results Reference
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    Microvascular Partial Toe Transfer

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