NCT01738919

Brief Summary

Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture. Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique. The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates. The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 4, 2016

Completed
Last Updated

November 4, 2016

Status Verified

September 1, 2016

Enrollment Period

4.1 years

First QC Date

November 28, 2012

Results QC Date

April 1, 2016

Last Update Submit

September 15, 2016

Conditions

Mallet Finger

Outcome Measures

Primary Outcomes (1)

  • Extension Deficit in the Affected Distal Interphalangeal Joint.

    Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)

    6 month

Secondary Outcomes (5)

  • Pain

    6 month

  • Bump

    6 month

  • Complications

    6 month

  • DASH

    6 month

  • Flexion of the Distal Interphalangeal Joint.

    6 months

Study Arms (2)

Non-subluxated - splinting

ACTIVE COMPARATOR

Conservative treatment with splinting for 6 weeks.

Procedure: Conservative treatment with splinting for 6 weeks.

Non-subluxated - operation

ACTIVE COMPARATOR

Operative treatment with extension block technique

Procedure: Operative treatment with extension block technique

Interventions

Conservative treatment with splinting for 6 weeks.PROCEDURE

Aluminum Karstam splints are used.

Non-subluxated - splinting
Operative treatment with extension block techniquePROCEDURE

Surgery with extension block technique. 6 weeks.

Also known as: K-wires (ø= 1 mm) are used.
Non-subluxated - operation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Mallet finger fractures with a \>1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges.
  • Fractures with a delay of \< 2 weeks.
  • With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.

You may not qualify if:

  • Open injuries
  • Mallet finger fracture of the thumb
  • Co-existing rheumatologic illness in the fingers
  • No-compliance patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hand Surgery, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Conservative TreatmentBone Wires

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Janni Kjaergaard Thillemann
Organization
Aarhus University Hospital
teamjanni@gmail.com
+45 28137303

Study Officials

  • Bo Munk, MD

    Department of Hand Surgery, Aarhus University Hospital, Denmark

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

April 1, 2011

Primary Completion

May 1, 2015

Study Completion

September 1, 2016

Last Updated

November 4, 2016

Results First Posted

November 4, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)