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

Primary Purpose

Finger Injury

Status

Withdrawn

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

extensor tendon repair

Mallet splint for 4 weeks

About this trial

This is an interventional treatment trial for Finger Injury focused on measuring Soft tissue mallet finger

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

soft tissue mallet finger
acute injury

Exclusion Criteria:

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

Sites / Locations

Mid Cheshire NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conservative

Surgery

Arm Description

Four weeks of splinting followed by mobilisation.

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

Outcomes

Primary Outcome Measures

DASH score

Secondary Outcome Measures

Range of movement at distal interphalyngeal joint.

Full Information

NCT ID

NCT01016197

First Posted

November 18, 2009

Last Updated

September 26, 2016

Sponsor

Mid Cheshire Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01016197

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Withdrawn

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mid Cheshire Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Finger Injury

Keywords

Soft tissue mallet finger

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conservative

Arm Type

Active Comparator

Arm Description

Four weeks of splinting followed by mobilisation.

Arm Title

Surgery

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

extensor tendon repair

Intervention Description

Surgical repair of extensor tendon with bone anchor and splinting

Intervention Type

Procedure

Intervention Name(s)

Mallet splint for 4 weeks

Intervention Description

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

Primary Outcome Measure Information:

Title

DASH score

Time Frame

up to 18 months

Secondary Outcome Measure Information:

Title

Range of movement at distal interphalyngeal joint.

Time Frame

3, 6, 12 and 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: soft tissue mallet finger acute injury Exclusion Criteria: ASA 3 or above Unable to give informed consent Infection in digit affected

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Holland, MBChB, MRCS

Organizational Affiliation

National Health Service, United Kingdom

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mid Cheshire NHS Trust

City

Crewe

ZIP/Postal Code

CW1 4QJ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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