跳至主要内容
临床试验/NCT06487676
NCT06487676已完成不适用

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

Chang Gung Memorial Hospital0 个研究点目标入组 75 人开始时间: 2015年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
主要终点
Michigan Hand Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Toe transfers
  • minimum 5 year follow up

排除标准

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

结局指标

主要结局

Michigan Hand Questionnaire

时间窗: Single time-point, on average 22 years after surgery

Validated Hand function patient reported outcome measured. 0-100. Higher is better

次要结局

  • 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)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

相似试验

Long Term Follow up of Toe-to-hand Transfers | 临床试验