NCT05155735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

November 1, 2021

Last Update Submit

January 19, 2023

Conditions

Amputation; Traumatic, Hand

Keywords

ReplantationSingle digitfunctionDASH

Outcome Measures

Primary Outcomes (3)

  • Functional outcome by DASH score

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

    Immediately following patient discharge from hand therapy

  • Functional outcome by Purdue Pegboard Test

    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)

    Immediately following patient discharge from hand therapy

  • Functional outcome by Michigan Hand Questionnaire

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

    Immediately following patient discharge from hand therapy

Study Arms (2)

Replantation

This group will include subjects who suffered a single digit non-thumb amputation, and whose finger was replanted.

Procedure: Replantation

Revision Amputation

This group will include subjects who suffered a single digit non-thumb amputation, and whose finger was not replanted.

Procedure: Primary wound closure

Interventions

ReplantationPROCEDURE

Surgical reattachment of a severed body part

Replantation
Primary wound closurePROCEDURE

Primary wound closure with removal of exposed bone

Revision Amputation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who have suffered a single digit amputation who are treated at the collaborating hospital centres

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal East, Quebec, H1T2M4, Canada

RECRUITING

Related Publications (5)

  • Stone N, Shah A, Chin B, McKinnon V, McRae M. Comparing digital replantation versus revision amputation patient reported outcomes for traumatic digital amputations of the hand: A systematic review and meta-analysis. Microsurgery. 2021 Jul;41(5):488-497. doi: 10.1002/micr.30738. Epub 2021 Apr 3.

    PMID: 33811398BACKGROUND

  • Kaplan FT, Raskin KB. Indications and surgical techniques for digit replantation. Bull Hosp Jt Dis. 2001-2002;60(3-4):179-88.

    PMID: 12102407BACKGROUND

  • Tejedor Navarro A, Vendrell Jorda M, Puente Alonso C. Digital replantation/revascularization: predictive factors to microsurgery success-a single-center study. Eur J Trauma Emerg Surg. 2021 Feb;47(1):225-232. doi: 10.1007/s00068-019-01226-x. Epub 2019 Sep 24.

    PMID: 31552437BACKGROUND

  • Zhu H, Bao B, Zheng X. A Comparison of Functional Outcomes and Therapeutic Costs: Single-Digit Replantation versus Revision Amputation. Plast Reconstr Surg. 2018 Feb;141(2):244e-249e. doi: 10.1097/PRS.0000000000004024.

    PMID: 29036026BACKGROUND

  • Shaterian A, Sayadi LR, Tiourin E, Gardner DJ, Evans GRD, Leis A. Predictors of Hand Function Following Digit Replantation: Quantitative Review and Meta-Analysis. Hand (N Y). 2021 Jan;16(1):11-17. doi: 10.1177/1558944719834658. Epub 2019 Apr 2.

    PMID: 30938181BACKGROUND

MeSH Terms

Interventions

Replantation

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Bruno Mastropasqua, MD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ophelie Doucet

CONTACT

5148908000ophelie.doucet@umontreal.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

December 14, 2021

Study Start

January 17, 2023

Primary Completion

May 15, 2024

Study Completion

November 15, 2024

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)