A Randomized Controlled Trial of the Treatment of Mallet Fractures

Conmed Linvatec Benelux

Status: Unknown

Conditions: Mallet Fracture

Treatments: Procedure: Biodegradable Meniscus Arrow®; Device: Mallet splint

Study type: Interventional

Funder types: Other

Identifiers

NCT01232426

Mallet2010

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Operative

Experimental group

Description:

operative treatment of a Mallet fracture with a biodegradable Meniscus Arrow®

Treatment:

Procedure: Biodegradable Meniscus Arrow®

Conservative

Active Comparator group

Description:

Conservative treatment of a Mallet fracture with a Mallet splint

Treatment:

Device: Mallet splint