Early Active Finger Exercises in Replanted Fingers

NCT ID: NCT03383640

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type OTHER

Active exercises

Intervention Type OTHER

Active flexion movements every waking hour of the replanted digits

Interventions

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Active exercises

Active flexion movements every waking hour of the replanted digits

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Johanne Korslund

Doctor, orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Johanne Korslund, Cand.med

Role: CONTACT

Phone: 004795961393

Email: [email protected]

Magne Røkkum, PhD

Role: CONTACT

Phone: 004723076025

Email: [email protected]

Other Identifiers

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2017/1282 D

Identifier Type: -

Identifier Source: org_study_id