Surgical Versus Conservative Treatment of Acute Mallet Fi... | NCT01016197

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

NCT01016197

Sponsor

Mid Cheshire Hospitals NHS Foundation Trust

Status

Withdrawn

Last Update Posted

Sep 27, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Finger Injury

Interventions

extensor tendon repair
Mallet splint for 4 weeks

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 18, 2009

First Submission Date that Met QC Criteria

Nov 18, 2009

First Posted Date

Nov 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conservative	Active Comparator	Four weeks of splinting followed by mobilisation.	Procedure: Mallet splint for 4 weeks
Surgery	Experimental	Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.	Procedure: extensor tendon repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
extensor tendon repair	Procedure	Surgical repair of extensor tendon with bone anchor and splinting	Surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DASH score		up to 18 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Holland, MBChB, MRCS	National Health Service, United Kingdom	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mid Cheshire NHS Trust		Crewe		CW1 4QJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D005383	Finger Injuries

Ancestor Terms

ID	Term
D006230	Hand Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided