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Long Term Follow up of Toe-to-hand Transfers

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06487676
Enrollment
75
Registered
2024-07-05
Start date
2015-07-31
Completion date
2023-10-27
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free Tissue Flap, Patient Reported Outcome Measures, Toe Transfer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREToe transfer

Toe-to-hand transfer

PROCEDUREReplantation

Finger or thumb replantation after amputation

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Michigan Hand QuestionnaireSingle time-point, on average 22 years after surgeryValidated Hand function patient reported outcome measured. 0-100. Higher is better

Secondary

MeasureTime frameDescription
Short Form 36Single time-point, on average 22 years after surgeryShort Form 36 Quality of Life. 0-100. Higher is better
Foot Function IndexSingle time-point, on average 22 years after surgeryValidated foot function Patient reported outcome measure. 0-100. Lower is better
Aesthetic evaluationLongitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgerySubjective evaluation of toe transfer appearance using a Visual Analogue Scale, not validated

Other

MeasureTime frameDescription
Grip strengthSingle time-point, on average 22 years after surgeryMeasured with hand dynamometer. Measured in kilograms.
SensationSingle time-point, on average 22 years after surgeryMeasured with discriminator device. Two point discrimination measured in millimetres
Range of motionSingle time-point, on average 22 years after surgeryTotal active range of motion of digit. Measured in degrees per digit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026