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Clinical Trials/NCT05155735
NCT05155735RecruitingNot Applicable

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

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country30 target enrollmentStarted: January 17, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Functional outcome by Purdue Pegboard Test

Study Overview

Brief Summary

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.

Detailed Description

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:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Functional outcome by Purdue Pegboard Test

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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