NCT01072760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

5.6 years

First QC Date

February 12, 2010

Last Update Submit

February 19, 2010

Conditions

Bony Mallet Finger

Keywords

Mallet fingerextensor tendonKirschner wireFracture Fixation

Outcome Measures

Primary Outcomes (1)

  • The digits were assessed for skin necrosis, skin breakdown, infection.

    15 days

Secondary Outcomes (1)

  • The patients rated their pain experience by a visual analogue scale. The results were graded by Crawford's criteria.

    1 year

Study Arms (1)

K wire

EXPERIMENTAL
Procedure: K wire

Interventions

K wirePROCEDURE

Mallet finger treatment

Also known as: stainless steel wire
K wire

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second hospital of Qinhuangdao

Qinhuangdao, Hebei, 066600, China

Location

Related Publications (1)

  • 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.

    PMID: 19880893RESULT

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Sumin Wen, M.D.

    The Second Hospital of Qinhuangdao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 22, 2010

Study Start

May 1, 2003

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

CN(1)