Repair of Thumb Defect by Using the Toe Nail Flap

Thumb Injury Clinical Trial

— RTDUTNF  

Official title:

Repair of Thumb Defect by Using the Toe Nail Flap: Biomechanical Analysis of Donor Foot ,a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879941
• Other study ID #: 2013-01-3
• Status: Completed
• Start date: March 1, 2013
• Est. completion date: June 1, 2018

Study information

• Verified date: March 2019
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 46 Years

Eligibility

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;

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

Related Conditions & MeSH terms

• Thumb Injury

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hebei Medical University	Tangshan Worker's Hospital, The Second Hospital of Tangshan

References & Publications (6)

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. Review. — View Citation

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

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. — View Citation

Pet MA, Ko JH, Vedder NB. Reconstruction of the traumatized thumb. Plast Reconstr Surg. 2014 Dec;134(6):1235-45. doi: 10.1097/PRS.0000000000000716. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Peak pressure	Its increase indicates that the pressure in the unit area increases when the sole touches the ground.	Six months
Primary	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
Primary	Contact time of each gait phase	The increase or decrease it reflects the stress distribution of sole after operation.	Six months
Primary	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