Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial

NCT ID: NCT01016197

Last Updated: 2016-09-27

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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The investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals.

Detailed Description

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The investigators will randomise patients to receive splinting of their finger while their tendon heals or have surgical intervention. Surgical intervention will entail fixing the tendon with bone anchors and splinting. Conservative treament involves splinting while the tendon heals. We will then monitor the functional outcome of the hand using the DASH questionare over 18 months.

Conditions

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Finger Injury

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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Conservative

Four weeks of splinting followed by mobilisation.

Group Type ACTIVE_COMPARATOR

Mallet splint for 4 weeks

Intervention Type PROCEDURE

The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.

Surgery

Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.

Group Type EXPERIMENTAL

extensor tendon repair

Intervention Type PROCEDURE

Surgical repair of extensor tendon with bone anchor and splinting

Interventions

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extensor tendon repair

Surgical repair of extensor tendon with bone anchor and splinting

Intervention Type PROCEDURE

Mallet splint for 4 weeks

The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* soft tissue mallet finger
* acute injury

Exclusion Criteria

* ASA 3 or above
* Unable to give informed consent
* Infection in digit affected
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mid Cheshire Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mersey Deanery

Principal Investigators

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Philip Holland, MBChB, MRCS

Role: PRINCIPAL_INVESTIGATOR

National Health Service, United Kingdom

Locations

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Mid Cheshire NHS Trust

Crewe, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PH1

Identifier Type: -

Identifier Source: org_study_id

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