NCT03879941

Brief Summary

The thumb accounts for 50% of the total hand function. This study reports the functional outcomes and complications of people with traumatic thumb amputations who underwent toe-to-thumb reconstruction.From 2013-01 to 2018-01, 29 patients with second-degree thumb defect underwent thumb reconstruction with distal phalangeal braided toenail flap. The footscan foot pressure gait analysis system was used to measure the index changes of the same foot before and after one, three and six months. The contact area, peak pressure, impulse value, contact time of each gait phase, centre of gravity coordinate and foot balance were analysed statistically. Twenty-nine cases of thumb reconstruction recovered well. After following up for 6-15 months, the appearance of the reconstructed thumb was close to normal, and the sensation was restored to S3+. The two-point discrimination was 6-8 mm, and the function of the thumb was good. The function of the donor foot was well restored, and no skin ulceration, pain and claudication were noted during walking. Compared with that before operation, the biomechanical indices of the donor foot were basically restored to normal six months after operation. Only the stress and impulse values of the third metatarsal head were significantly increased, forming a stress concentration area centred on the third metatarsal head.This study confirmed that the toe nail flap with distal phalangeal bone restored the second-degree thumb defect without destroying the main functional structure of the sole. The biomechanical indices of the donor foot were basically restored to normal six months after operation. Only the stress concentration area centred on the third metatarsal head, and the pain on the forefoot was induced after the operation. Discomfort, callus formation, metatarsal fasciitis, etc. can lead to fatigue fracture of the third metatarsal bone in severe cases, which requires further follow-up and observation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

March 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

5 years

First QC Date

March 13, 2019

Last Update Submit

March 14, 2019

Conditions

Keywords

Amputationthumb reconstructiontoe transferfoot morbiditybiomechanics

Outcome Measures

Primary Outcomes (5)

  • The contact area

    According to the anatomical region, the plantar was divided into eight stress regions.The increase or decrease of contact area reflects the stress distribution of sole after operation.

    Six months

  • Peak pressure

    Its increase indicates that the pressure in the unit area increases when the sole touches the ground.

    Six months

  • Impulse value

    Impulse value refers to the product of touchdown time and pressure in each stress area of the foot in each cycle. The increase of impulse is more suggestive of fatigue damage and subsequent foot deformities.

    Six months

  • Contact time of each gait phase

    The increase or decrease it reflects the stress distribution of sole after operation.

    Six months

  • Foot balance

    Foot balance refers to the difference of compressive stress between the inside and the outside of the foot at a certain time.

    Six months

Eligibility Criteria

Age17 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The causes of injury were as follows: 2 cases of amputation and loss, 21 cases of machine rolling damage, 5 cases of rotational tear and replantation failure and 1 case of childhood traumatic defect. The patients included 19 males and 10 females with age of 17-46 years (mean 29.1 years), height of 156-179 cm (average 170.4 cm), weight of 50-80 kg (average 62.3 kg) and foot length of 23-26 cm (average 24.5 cm). The defect cases included 12 on the left side of the toe and 17 on the right side.

You may qualify if:

  • patients with second-degree thumb defect;
  • without any foot disease or deformity before injury;
  • Written informed consent to undergo the surgical procedure;

You may not qualify if:

  • Concomitant phalanx fractures or other injuries needing immobilization;
  • Loss of skin substance requiring grafts or flaps
  • Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Foucher G. Second toe-to-finger transfer in hand mutilations. Clin Orthop Relat Res. 1995 May;(314):8-12.

    PMID: 7634655BACKGROUND
  • Pet MA, Ko JH, Vedder NB. Reconstruction of the traumatized thumb. Plast Reconstr Surg. 2014 Dec;134(6):1235-1245. doi: 10.1097/PRS.0000000000000716.

    PMID: 25255109BACKGROUND
  • Sabapathy SR, Venkatramani H, Bhardwaj P. Reconstruction of the thumb amputation at the carpometacarpal joint level by groin flap and second toe transfer. Injury. 2013 Mar;44(3):370-5. doi: 10.1016/j.injury.2013.01.012. Epub 2013 Jan 20.

    PMID: 23340236BACKGROUND
  • Lee KS, Chae IJ, Hahn SB. Thumb reconstruction with a free neurovascular wrap-around flap from the big toe: long-term follow-up of thirty cases. Microsurgery. 1995;16(10):692-7. doi: 10.1002/micr.1920161007.

    PMID: 8676733BACKGROUND
  • Woo SH, Yoo MJ, Paeng JW. Recent Advances in Immediate Toe-to-Hand Transfer. J Hand Surg Asian Pac Vol. 2016 Oct;21(3):292-9. doi: 10.1142/S2424835516400099.

    PMID: 27595944BACKGROUND
  • Buldt AK, Allan JJ, Landorf KB, Menz HB. The relationship between foot posture and plantar pressure during walking in adults: A systematic review. Gait Posture. 2018 May;62:56-67. doi: 10.1016/j.gaitpost.2018.02.026. Epub 2018 Feb 23.

    PMID: 29524798BACKGROUND
  • Liu C, Liu L, Liu G, Tian S, Bai J, Yu K, Tian D. Repair of thumb defect by using the toenail flap: biomechanical analysis of donor foot-a retrospective cohort study. J Orthop Surg Res. 2019 Sep 2;14(1):287. doi: 10.1186/s13018-019-1330-7.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 19, 2019

Study Start

March 1, 2013

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03