A Randomized Controlled Trial of the Treatment of Mallet Fractures

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01232426

Enrollment

Registered

2010-11-02

Start date

2011-03-31

Completion date

Unknown

Last updated

2012-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mallet Fracture

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.

Interventions

PROCEDUREBiodegradable Meniscus Arrow®

Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®

DEVICEMallet splint

Conservative treatment of the Mallet fracture with the traditional Mallet splint.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
wound healing disturbances	1 year	at every control, this is noted

Other

Measure	Time frame	Description
nail deformaties	1 year	at every control nail deformaties, if present, are noted

Countries

Netherlands

Contacts

Primary ContactD Wouters, MD, PhD

dwouters@tsz.nl+31-134655655

Backup ContactFLM Aarts, MD

flmaarts@gmail.com+31-639778708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026