Clinical trial NCT06487676: Long Term Follow up of Toe-to-hand Transfers
Official title: Long Term Follow up of Toe-to-hand Transfers: Validated Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Toe Transfer
Free Tissue Flap
Patient Reported Outcome Measures
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on by single surgeon (FCW) at Chang Gung Memorial Hospital from 1983 to 2015, with at least 5 years follow up at time of inclusion to study

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.

Eligibility criteria: 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

Primary outcomes:
measure: Michigan Hand Questionnaire
timeFrame: Single time-point, on average 22 years after surgery
Secondary outcomes:
measure: Short Form 36
timeFrame: Single time-point, on average 22 years after surgery
measure: Foot Function Index
timeFrame: Single time-point, on average 22 years after surgery
measure: Aesthetic evaluation
timeFrame: Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery
Other outcomes:
measure: Range of motion
timeFrame: Single time-point, on average 22 years after surgery
measure: Grip strength
timeFrame: Single time-point, on average 22 years after surgery
measure: Sensation
timeFrame: Single time-point, on average 22 years after surgery
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Fu Chan Wei, FACS
role: PRINCIPAL_INVESTIGATOR
References: