A Randomized Controlled Trial of the Treatment of Mallet Fractures

Mallet Fracture Clinical Trial

Official title:

A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01232426
• Other study ID #: Mallet2010
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2010
• Last updated: August 17, 2012
• Start date: March 2011

Study information

• Verified date: August 2012
• Source: Conmed Linvatec Benelux
• Contact: D Wouters, MD, PhD
• Phone: +31-134655655
• Email: dwouters[@]tsz.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Mallet Fracture

Intervention

Procedure:
• Biodegradable Meniscus Arrow®
Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®

Device:
• Mallet splint
Conservative treatment of the Mallet fracture with the traditional Mallet splint.

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda	Noord-Brabant
Netherlands	Catharaina Hospital	Eindhoven	Noord-Brabant
Netherlands	Kennemer Gasthuis Hospital	Haarlem	Noord-Holland
Netherlands	Canisius-Wilhelmina Hospital	Nijmegen
Netherlands	st. Elisabeth Hospital	Tilburg	Noord-Barbant
Netherlands	Twee Steden Hospital	Tilburg	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Conmed Linvatec Benelux

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Nelis R, Wouters DB. Is the use of biodegradable devices in the operative treatment of avulsion fractures of fingers, the so-called mallet finger advantageous? A feasibility study with meniscus arrows. Open Orthop J. 2008 Nov 3;2:151-4. doi: 10.2174/1874325000802010151. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	nail deformaties	at every control nail deformaties, if present, are noted	1 year	No
Primary	Extension deficit	To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.	1 year	No
Primary	extension deficit	at every visit, the extension in the DIP joint, is measured	1 year	No
Secondary	wound healing disturbances	at every control, this is noted	1 year	No