- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192084
Microvascular Partial Toe Transfer
Microvascular Partial Toe Transfer for Reconstruction of Traumatic Amputations of the Digits
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
we will perform microvascular partial toe transfer for patients with traumatic amputation of one or more digits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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/) |
six months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lutz BS, Wei FC. Basic principles on toe-to-hand transplantation. Chang Gung Med J. 2002 Sep;25(9):568-76.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Toe Transfer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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