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

September 26, 2016 updated by: Mid Cheshire Hospitals NHS Foundation Trust
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Crewe, United Kingdom, CW1 4QJ
        • Mid Cheshire NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • soft tissue mallet finger
  • acute injury

Exclusion Criteria:

  • ASA 3 or above
  • Unable to give informed consent
  • Infection in digit affected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conservative
Four weeks of splinting followed by mobilisation.
Procedure: Mallet splint for 4 weeks
The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.
Experimental: Surgery
Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.
Procedure: extensor tendon repair
Surgical repair of extensor tendon with bone anchor and splinting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DASH score
Time Frame: up to 18 months
up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of movement at distal interphalyngeal joint.
Time Frame: 3, 6, 12 and 18 months
3, 6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid Cheshire Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Philip Holland, MBChB, MRCS, National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 19, 2009

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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