Extension Block Technique Versus Splinting in Mallet Finger Fracture. (Ishiguro)
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|ClinicalTrials.gov Identifier: NCT01738919|
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : November 4, 2016
Last Update Posted : November 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Mallet Finger||Procedure: Conservative treatment with splinting for 6 weeks. Procedure: Operative treatment with extension block technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||September 2016|
Active Comparator: Non-subluxated - splinting
Conservative treatment with splinting for 6 weeks.
Procedure: Conservative treatment with splinting for 6 weeks.
Aluminum Karstam splints are used.
Active Comparator: Non-subluxated - operation
Operative treatment with extension block technique
Procedure: Operative treatment with extension block technique
Surgery with extension block technique. 6 weeks.
Other Name: K-wires (ø= 1 mm) are used.
- Extension Deficit in the Affected Distal Interphalangeal Joint. [ Time Frame: 6 month ]Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)
- Pain [ Time Frame: 6 month ]Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.
- Bump [ Time Frame: 6 month ]Number of participants with the presence of a bump on the fracture-site.
- Complications [ Time Frame: 6 month ]Number of participants with nail deformities.
- DASH [ Time Frame: 6 month ]Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.
- Flexion of the Distal Interphalangeal Joint. [ Time Frame: 6 months ]Flexion of the distal interphalangeal joint. Measured with goniometer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738919
|Department of Hand Surgery, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Study Chair:||Bo Munk, MD||Department of Hand Surgery, Aarhus University Hospital, Denmark|