Long Term Follow up of Toe-to-hand Transfers

NCT06487676 | Completed

• 1 other identifier: 201505775B0C104
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Toe Transfer; Free Tissue Flap; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Short Form 36

  Single time-point, on average 22 years after surgery

• Foot Function Index

  Single time-point, on average 22 years after surgery

• Aesthetic evaluation

  Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery

Other Outcomes (3)

• Range of motion

  Single time-point, on average 22 years after surgery

• Grip strength

  Single time-point, on average 22 years after surgery

• Sensation

  Single time-point, on average 22 years after surgery

Study Arms (2)

Toe transfer

Patients who have undergone toe to hand transfer

Procedure: Toe transfer

Replantation

Patients who have undergone finger replantation

Procedure: Replantation

Interventions

Toe transfer PROCEDURE

Toe-to-hand transfer

Toe transfer

Replantation PROCEDURE

Finger or thumb replantation after amputation

Also known as: Finger or thumb replantation

Replantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Toe transfers
• minimum 5 year follow up

You may not qualify if:

• partial toe transfers including toenail, toe pulp or vascularised joint
• under 5 year follow up

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Interventions

Replantation

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Fu Chan Wei, FACS

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: July 5, 2024
• Study Start: July 31, 2015
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-05