Recruiting

Replantation vs. Amputation

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05155735

Conditions

Amputation; Traumatic, Hand

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Replantation

Primary wound closure

Study Details

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.

Conditions

Amputation; Traumatic, Hand

Study ID

NCT05155735

Start date

Jan 17, 2023

Status verified date

Jan, 2023

Completion date

Nov 15, 2024

Anticipated

Primary completion date

May 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Replantation

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

Revision Amputation

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

Interventions

Replantation

Surgical reattachment of a severed body part

Primary wound closure

Primary wound closure with removal of exposed bone

Primary outcome measure

  • Functional outcome by DASH score [ Time Frame: Immediately following patient discharge from hand therapy ]
  • Functional outcome by Purdue Pegboard Test [ Time Frame: Immediately following patient discharge from hand therapy ]
  • Functional outcome by Michigan Hand Questionnaire [ Time Frame: Immediately following patient discharge from hand therapy ]

Central Contacts and Locations

Central contacts

Ophelie Doucet

5148908000ophelie.doucet@umontreal.ca

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montréal-Est, Quebec, Canada, H1T2M4

Contacts

Ophelie Doucet, MD

438-882-9681ophelie.doucet@umontreal.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Jan 23, 2023

Last verified

Jan, 2023

Keywords

  • Replantation
  • Single digit
  • function
  • DASH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2023-01-23.