A Randomized Controlled Trial of the Treatment of Mallet Fractures

Not Applicable

• Conditions: Mallet Fracture
• Interventions: Procedure: Biodegradable Meniscus Arrow®; Device: Mallet splint

• Registration Number: NCT01232426
• Lead Sponsor: Conmed Linvatec Benelux

Brief Summary

Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as Mallet fractures. Treatment of Mallet fractures remains controversial. Although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. There are many different operative techniques, all with specific disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet splint.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-31
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Study Start: 2011-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-20
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• avulsion fracture involving more than 30% of articular surface

Exclusion Criteria

• (sub)luxation of the distal phalanx
• patients with a Mallet fracture developed 3 weeks or more prior to presentation
• patients with a Mallet fracture with failure of conservative treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative	Biodegradable Meniscus Arrow®	operative treatment of a Mallet fracture with a biodegradable Meniscus Arrow®
Conservative	Mallet splint	Conservative treatment of a Mallet fracture with a Mallet splint

Primary Outcome Measures

Name	Time	Method
Extension deficit	1 year	To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.
extension deficit	1 year	at every visit, the extension in the DIP joint, is measured

Secondary Outcome Measures

Name	Time	Method
wound healing disturbances	1 year	at every control, this is noted

Trial Locations

Locations (6)

Catharaina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

st. Elisabeth Hospital; 🇳🇱 Tilburg, Noord-Barbant, Netherlands

Amphia Hospital; 🇳🇱 Breda, Noord-Brabant, Netherlands

Twee Steden Hospital; 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Canisius-Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands

Kennemer Gasthuis Hospital; 🇳🇱 Haarlem, Noord-Holland, Netherlands