Long Term Follow up of Toe-to-hand Transfers

Long Term Follow up of Toe-to-hand Transfers: Validated Patient Reported Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Patient Reported Outcome Measures; Toe Transfer; Free Tissue Flap
• Intervention / Treatment: Procedure: Toe transfer; Procedure: Replantation

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.

• Study Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Toe transfer; Patients who have undergone toe to hand transfer	Procedure: Toe transfer; Toe-to-hand transfer
Replantation; Patients who have undergone finger replantation	Procedure: Replantation; Finger or thumb replantation after amputation; Other Names: Finger or thumb replantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Questionnaire	Validated Hand function patient reported outcome measured. 0-100. Higher is better	Single time-point, on average 22 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36	Short Form 36 Quality of Life. 0-100. Higher is better	Single time-point, on average 22 years after surgery
Foot Function Index	Validated foot function Patient reported outcome measure. 0-100. Lower is better	Single time-point, on average 22 years after surgery
Aesthetic evaluation	Subjective evaluation of toe transfer appearance using a Visual Analogue Scale, not validated	Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Total active range of motion of digit. Measured in degrees per digit	Single time-point, on average 22 years after surgery
Grip strength	Measured with hand dynamometer. Measured in kilograms.	Single time-point, on average 22 years after surgery
Sensation	Measured with discriminator device. Two point discrimination measured in millimetres	Single time-point, on average 22 years after surgery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Fu Chan Wei, FACS, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2015
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201505775B0C104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data subject to privacy and legal restrictions - not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No