Extension Block Technique Versus Splinting in Mallet Finger Fracture.

Mallet Finger Clinical Trial

— Ishiguro  

Official title:

Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01738919
• Other study ID #: Janni1
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2012
• Last updated: December 3, 2012
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2012
• Source: University of Aarhus
• Contact: Janni K Thillemann, MD
• Phone: +45 28137303
• Email: teamjanni[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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, IC, IIB and IIC are included.

Exclusion Criteria:

• Open injuries

• Mallet finger fracture of the thumb

• Co-existing rheumatologic illness in the fingers

• No-compliance patient

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mallet Finger

Intervention

Procedure:
• Conservative treatment with splinting for 6 weeks.
Aluminum Karstam splints are used.
• Operative treatment with extension block technique

Locations

Country	Name	City	State
Denmark	Department of Hand Surgery, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extension deficit	Extension deficit measured in degrees, using goniometry.	6 month	No
Secondary	Range of motion (ROM)	(ROM)measured in the injured joint, using goniometry. Degrees.	6 month	No
Secondary	Pain	Pain in the affected join, using the VAS-scale.	6 month	No
Secondary	Bump	Presence of bump on the fracture-site. Objective examination.	6 month	No
Secondary	Complications	Objective examination for: swan neck deformity; skin necrosis; nail deformities; infection; non-union(x-ray)	6 month	No
Secondary	DASH	Questionary: Disabilities of the Arm, Shoulder and Hand Danish version	6 month	No
Secondary	Crawford score	Crawford score-scale.	6 month	No