Repair of Thumb Defect by Using the Toe Nail Flap

Completed

• Conditions: Thumb Injury

• Registration Number: NCT03879941
• Lead Sponsor: Hebei Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-06-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The contact area	Six months	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.
Peak pressure	Six months	Its increase indicates that the pressure in the unit area increases when the sole touches the ground.
Contact time of each gait phase	Six months	The increase or decrease it reflects the stress distribution of sole after operation.
Foot balance	Six months	Foot balance refers to the difference of compressive stress between the inside and the outside of the foot at a certain time.
Impulse value	Six months	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.