NCT04192084

Brief Summary

Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

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

November 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

November 29, 2019

Last Update Submit

December 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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/)

    six months

Study Arms (1)

Traumatic amputations of the digits

EXPERIMENTAL

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

Procedure: microvascular partial toe transfer

Interventions

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

Traumatic amputations of the digits

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 4959061BACKGROUND
  • 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.

    PMID: 5371970BACKGROUND
  • 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.

    PMID: 3340671BACKGROUND
  • 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.

    PMID: 10541171BACKGROUND
  • 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.

    PMID: 3351225BACKGROUND
  • 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.

    PMID: 4052709BACKGROUND
  • 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.

    PMID: 1924570BACKGROUND
  • 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.

    PMID: 8942916BACKGROUND
  • Lutz BS, Wei FC. Basic principles on toe-to-hand transplantation. Chang Gung Med J. 2002 Sep;25(9):568-76.

    PMID: 12479617BACKGROUND
  • 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.

    PMID: 22942845BACKGROUND
  • 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.

    PMID: 9858192BACKGROUND
  • 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.

    PMID: 7574290BACKGROUND
  • 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.

    PMID: 6386954BACKGROUND
  • 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.

    PMID: 7000885BACKGROUND
  • 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.

    PMID: 8700986BACKGROUND

MeSH Terms

Conditions

Amputation, TraumaticHand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 10, 2019

Study Start

December 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share