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临床试验/NCT05155735
NCT05155735招募中不适用

Functional Outcomes of Single Digit Replantation Versus Revision Amputation, a Prospective Study

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Functional outcome by Purdue Pegboard Test

研究概览

简要总结

The purpose of this study is to compare functional outcomes in single digit replantation subjects compared with revision amputation. Functional outcomes will be assessed by DASH (disabilities of the arm, shoulder and hand) score and with Purdue Pegboard Test by the subject's respective hand therapist at their last visit. Results will contribute to generating a preoperative decision algorithm for single digit amputation injuries.

详细描述

Research design: Prospective observational cohort study

Study population, enrollment, and duration of participation:

Collaborating institutions Revision amputation cohort: CHUM, Santa Cabrini Hospital and Maisonneuve Rosemont Hospital Replantation cohort: CEVARMU/CHUM

Inclusion Criteria: All replantation and revision amputation of single digits who are treated at the collaborating hospital centres Exclusion Criteria: Thumb amputation, Multiple digit amputation, Failure to follow-up with an occupational therapist

Enrollment:

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Replantation of single digits treated at collaborating hospital centres
  • Revision amputation of single digits treated at collaborating hospital centres

排除标准

  • Thumb amputation
  • Multiple digit amputation
  • Failure to follow-up with hand therapist

结局指标

主要结局

Functional outcome by Purdue Pegboard Test

时间窗: Immediately following patient discharge from hand therapy

Measured by Purdue Pegboard Test (higher scores indicate a greater level of dexterity and functionality and are typically compared with normative data stratified on the basis of age, score range depends on how the test is administered)

Functional outcome by Michigan Hand Questionnaire

时间窗: Immediately following patient discharge from hand therapy

Measured by Michigan Hand Questionnaire (higher scores indicate a greater level of functionality, score range from 0 to 100)

Functional outcome by DASH score

时间窗: Immediately following patient discharge from hand therapy

Measured by DASH score (higher scores indicate a greater level of disability, score range from 0 to 100)

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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