Kirschner Wire and Pull-out Wire Fixation for the Treatme... | NCT01072760

Studies
Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger

NCT01072760

Sponsor

The Second Hospital of Qinhuangdao

Status

Completed

Last Update Posted

Feb 22, 2010Estimated

Enrollment

54Actual

Phase

Not Applicable

Conditions

Bony Mallet Finger

Interventions

K wire

Countries

China

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

ID	Type	Description	Link
QHD20010201	Other Identifier	The second hospital of Qinhuangdao

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Dec 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 19, 2010

First Posted Date

Feb 22, 2010Estimated

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

Feb 19, 2010

Last Update Posted Date

Feb 22, 2010Estimated

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 objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications.

Detailed Description

From May 2003 to December 2008, we used Kirschner wire and pull-out wire fixation to carry out 54 closed bony mallet finger in 54 patients. The bony mallet finger was applicated both Kirschner wire and pull-out wire fixation.

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

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
K wire	Experimental		Procedure: K wire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K wire	Procedure	Mallet finger treatment	K wire	stainless steel wire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The digits were assessed for skin necrosis, skin breakdown, infection.		15 days

Secondary Outcomes

Measure	Description	Time Frame
The patients rated their pain experience by a visual analogue scale. The results were graded by Crawford's criteria.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bony mallet finger;
patient had failed trials of nonsurgical treatment;
fracture involving more than 1/3 of the joint surface;
fragment displacement or subluxation of the DIP joint.

Exclusion Criteria:

tendinous mallet finger;
success of nonsurgical treatment;
comminuted fracture;
fracture involving at or less than 1/3 of the joint surface which could be successfully replaced with nonsurgical treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

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
Sumin Wen, M.D.	The Second Hospital of Qinhuangdao	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The second hospital of Qinhuangdao		Qinhuangdao	Hebei	066600	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19880893	Result	Lee YH, Kim JY, Chung MS, Baek GH, Gong HS, Lee SK. Two extension block Kirschner wire technique for mallet finger fractures. J Bone Joint Surg Br. 2009 Nov;91(11):1478-81. doi: 10.1302/0301-620X.91B11.22478.

ID	Term
D016268	Internal Fixators
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D009984	Orthopedic Fixation Devices