Long Term Follow up of Toe-to-hand Transfers

NCT ID: NCT06487676

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2023-10-27

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.

Conditions

Toe Transfer; Free Tissue Flap; Patient Reported Outcome Measures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Toe transfer

Patients who have undergone toe to hand transfer

Toe transfer

Intervention Type: PROCEDURE

Toe-to-hand transfer

Replantation

Patients who have undergone finger replantation

Replantation

Intervention Type: PROCEDURE

Finger or thumb replantation after amputation

Interventions

Toe transfer

Toe-to-hand transfer

Intervention Type: PROCEDURE

Replantation

Finger or thumb replantation after amputation

Intervention Type: PROCEDURE

Other Intervention Names

Finger or thumb replantation

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fu Chan Wei, FACS

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Other Identifiers

201505775B0C104

Identifier Type: -

Identifier Source: org_study_id