An observational study in Toe Transfer, Free Tissue Flap and Patient Reported Outcome Measures, sponsored by Chang Gung Memorial Hospital. Completed. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Chang Gung Memorial Hospital · Observational
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.
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.
Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients who have undergone toe to hand transfer
Procedure: Toe transfer
Patients who have undergone finger replantation
Procedure: Replantation
Toe-to-hand transfer
Finger or thumb replantation after amputation
Also known as: Finger or thumb replantation
Michigan Hand Questionnaire
Validated Hand function patient reported outcome measured. 0-100. Higher is better
Time frame: Single time-point, on average 22 years after surgery
Short Form 36
Short Form 36 Quality of Life. 0-100. Higher is better
Time frame: Single time-point, on average 22 years after surgery
Foot Function Index
Validated foot function Patient reported outcome measure. 0-100. Lower is better
Time frame: Single time-point, on average 22 years after surgery
Aesthetic evaluation
Subjective evaluation of toe transfer appearance using a Visual Analogue Scale, not validated
Time frame: Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery
Range of motion
Total active range of motion of digit. Measured in degrees per digit
Time frame: Single time-point, on average 22 years after surgery
Grip strength
Measured with hand dynamometer. Measured in kilograms.
Time frame: Single time-point, on average 22 years after surgery
Sensation
Measured with discriminator device. Two point discrimination measured in millimetres
Time frame: Single time-point, on average 22 years after surgery
No study locations are listed for this record.
Plan to share: Undecided — Data subject to privacy and legal restrictions - not yet decided
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital