NCT03383640

Brief Summary

A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

December 15, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

December 15, 2017

Last Update Submit

December 19, 2017

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

  • TAM

    Total active movement of the interphalangeal joints

    12 months

Secondary Outcomes (5)

  • Quick-DASH

    12 months

  • VAS Pain

    12 months

  • VAS Function

    12 months

  • Grip strength

    12 months

  • Key pinch

    12 months

Study Arms (2)

Control

NO INTERVENTION

Control Group: Standardized post operative rehabilitation, where active exercises of the replanted digits is postponed until radiologic healing of the amputated bone.

Intervention

OTHER

Intervention Group: Early active exercises of the replanted digits started between day 5 and 7 after surgery, as instructed by hand therapist

Other: Active exercises

Interventions

Active exercisesOTHER

Active flexion movements every waking hour of the replanted digits

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Total or subtotal amputation injury of 1-4 of the four ulnar digits
  • Injury distal to the MCP joint
  • Must have injured flexor tendon which requires suture
  • Must have a fracture
  • Surgery done with a stable osteosynthesis with acceptable post-operative x-ray imaging
  • The finger must have had a stable circulation for at least 5 days post-surgery

You may not qualify if:

  • Arthrodesis/temporary fixation of the MCP joint
  • Bilateral amputation injury
  • Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
  • Patients who cannot follow the planned controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Johanne Korslund, Cand.med

CONTACT

004795961393johanne.korslund@ous-hf.no

Magne Røkkum, PhD

CONTACT

004723076025mrokkum@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, orthopaedic surgeon

Study Record Dates

First Submitted

December 15, 2017

First Posted

December 26, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 5, 2021

Last Updated

December 26, 2017

Record last verified: 2017-12