Ignite Creation Date:
2024-07-17 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487676
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-05-05
Brief Title:
Long Term Follow up of Toe-to-hand Transfers
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Long Term Follow up of Toe-to-hand Transfers Validated Patient Reported Outcomes
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3417 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
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 3417 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None