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Microvascular Partial Toe Transfer

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ClinicalTrials.gov Identifier: NCT04192084
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yousif Tarek El-Gammal, Assiut University

Brief Summary:
Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits

Condition or disease Intervention/treatment Phase
Amputation, Traumatic Hand Injuries Procedure: microvascular partial toe transfer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microvascular Partial Toe Transfer for Reconstruction of Traumatic Amputations of the Digits
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Traumatic amputations of the digits
we will perform microvascular partial toe transfer for patients with traumatic amputations of one or more digits
Procedure: microvascular partial toe transfer
we will perform microvascular partial toe transfer for patients with traumatic amputation of one or more digits




Primary Outcome Measures :
  1. short-term functional outcome [ Time Frame: six months ]

    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/)




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Publications:

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Responsible Party: Yousif Tarek El-Gammal, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04192084    
Other Study ID Numbers: Toe Transfer
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hand Injuries
Amputation, Traumatic
Wounds and Injuries