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A Randomized Controlled Trial of the Treatment of Mallet Fractures

NCT01232426 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2012-08-20

No results posted yet for this study

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.

Conditions

  • Mallet Fracture

Interventions

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.

Sponsors & Collaborators

  • Conmed Linvatec Benelux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232426 on ClinicalTrials.gov