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Thumb InjuryRTDUTNFNCT03879941

Repair of Thumb Defect by Using the Toe Nail Flap

An observational study of Thumb Injury, run by Hebei Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 17 to 46 years
Conditions the study is for
Thumb Injury
How many people
29 participants
Where
No sites listed yet
Study dates
1 Mar 2013to 1 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 46 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Conditions
Thumb Injury
Keywords
Amputation, thumb reconstruction, toe transfer, foot morbidity, biomechanics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Six months

  2. Peak pressure

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

    Measured: Six months

  3. 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.

    Measured: Six months

  4. Contact time of each gait phase

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

    Measured: Six months

  5. Foot balance

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

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start1 Mar 2013
  3. Primary completion1 Mar 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879941
Sponsor's protocol ID
2013-01-3
Acronym
RTDUTNF
Status last verified
Mar 2019
First submitted
13 Mar 2019
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

    PubMed 7634655

  • 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.

    PubMed 25255109

  • 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.

    PubMed 23340236

  • 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.

    PubMed 8676733

  • 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.

    PubMed 27595944

  • 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.

    PubMed 29524798

  • 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.

    PubMed 31477182

Questions about this trial

What is this clinical trial studying?

An observational study of Thumb Injury, run by Hebei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The contact area (time frame: Six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879941, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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