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
About this trial
This is an interventional treatment trial for Amputation, Traumatic
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 .
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
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
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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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
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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Results Reference
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Microvascular Partial Toe Transfer
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