Repair of Thumb Defect by Using the Toe Nail Flap
RTDUTNF
1 other identifier
observational
29
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedMarch 19, 2019
March 1, 2019
5 years
March 13, 2019
March 14, 2019
Conditions
Keywords
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
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
- Hebei Medical Universitylead
- Tangshan Worker's Hospitalcollaborator
- The Second Hospital of Tangshancollaborator
Related Publications (7)
Foucher G. Second toe-to-finger transfer in hand mutilations. Clin Orthop Relat Res. 1995 May;(314):8-12.
PMID: 7634655BACKGROUNDPet 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: 25255109BACKGROUNDSabapathy 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: 23340236BACKGROUNDLee 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: 8676733BACKGROUNDWoo 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: 27595944BACKGROUNDBuldt 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: 29524798BACKGROUNDLiu 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.
PMID: 31477182DERIVED
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