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Completed

NCT Number: NCT06487676

Long Term Follow up of Toe-to-hand Transfers

Toe transfers are perceived to have changed the landscape of the injured hand over the last half century, yet there are limited validated data that unequivocally support the functional role of toe transfers after traumatic digital amputation. There also remain unanswered questions about what factors critically influence functional outcomes, be it sensory recovery, grip strength or other modality. Furthermore, the use of validated patient reported outcome measures (PROMs) in large series of toe transfers with long term follow up, is lacking.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

Finger amputations are associated with profound impacts on physical, socio-economic, vocational and mental well-being. Thumb amputations account for the greatest burden of disability globally amongst hand trauma.

The multi-centre FRANCHISE study and a recent large prospective multi-centre study have demonstrated that finger replantation outperforms equivalent amputations in nearly all digits at all levels, except for the little finger. However, one crucial question in hand surgery is whether toe transfers can provide a similar functional benefit to replantation.

Finger amputations are frequently not replantable even with timely access to specialized reconstructive care. A review of replantation in the USA found that of 3,417 digital amputations, only 631 replantations were attempted (18%), and of these 30% failed. Therefore nearly 90% of patients with finger amputations will ultimately live without the amputated digit.

Microvascular toe-to-hand transfer, first described in the 1960s, has a success rate close to 100% in high volume centres. There are few validated data that support the functional benefits of toe transfer, with the majority of outcome studies focusing on operative survival rates, physical measurements such as grip strength, or employ unvalidated scales and self-created questionnaires. More data, in larger more representative populations, using validated PROMs, is required.

Here, we aim to demonstrate using PROMS that the role of toe transfers has equivalent or improved functional benefits, with comparison to finger replantation. Additionally, this study aims to identify physical factors that have the greatest influence on patient reported outcomes. This may answer fundamental questions regarding optimum strategies for the design of toe transfers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Toe transfers
  • minimum 5 year follow up

Exclusion criteria

  • partial toe transfers including toenail, toe pulp or vascularised joint
  • under 5 year follow up

Treatment and study plan

Toe transfer

Procedure

Toe-to-hand transfer

Replantation

Procedure

Finger or thumb replantation after amputation

Other names: Finger or thumb replantation

Primary outcomes

  1. Michigan Hand Questionnaire

    Time frame: Single time-point, on average 22 years after surgery

    Validated Hand function patient reported outcome measured. 0-100. Higher is better

Secondary outcomes

  1. Short Form 36

    Time frame: Single time-point, on average 22 years after surgery

    Short Form 36 Quality of Life. 0-100. Higher is better

  2. Foot Function Index

    Time frame: Single time-point, on average 22 years after surgery

    Validated foot function Patient reported outcome measure. 0-100. Lower is better

  3. Aesthetic evaluation

    Time frame: Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery

    Subjective evaluation of toe transfer appearance using a Visual Analogue Scale, not validated

Other outcomes

  1. Range of motion

    Time frame: Single time-point, on average 22 years after surgery

    Total active range of motion of digit. Measured in degrees per digit

  2. Grip strength

    Time frame: Single time-point, on average 22 years after surgery

    Measured with hand dynamometer. Measured in kilograms.

  3. Sensation

    Time frame: Single time-point, on average 22 years after surgery

    Measured with discriminator device. Two point discrimination measured in millimetres

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Long Term Follow up of Toe-to-hand Transfers: Validated Patient Reported Outcomes

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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