Long Term Follow up of Toe-to-hand Transfers
- Conditions
- Toe TransferFree Tissue FlapPatient Reported Outcome Measures
- Interventions
- Procedure: Toe transferProcedure: Replantation
- Registration Number
- NCT06487676
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Toe transfers
- minimum 5 year follow up
- partial toe transfers including toenail, toe pulp or vascularised joint
- under 5 year follow up
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Toe transfer Toe transfer Patients who have undergone toe to hand transfer Replantation Replantation Patients who have undergone finger replantation
- Primary Outcome Measures
Name Time Method Michigan Hand Questionnaire Single time-point, on average 22 years after surgery Validated Hand function patient reported outcome measured. 0-100. Higher is better
- Secondary Outcome Measures
Name Time Method Short Form 36 Single time-point, on average 22 years after surgery Short Form 36 Quality of Life. 0-100. Higher is better
Foot Function Index Single time-point, on average 22 years after surgery Validated foot function Patient reported outcome measure. 0-100. Lower is better
Aesthetic evaluation 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