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A Randomized Controlled Trial of the Treatment of Mallet Fractures

NCT ID: NCT01232426

Last Updated: 2012-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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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

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Conditions

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Mallet Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative

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

Group Type EXPERIMENTAL

Biodegradable Meniscus Arrow®

Intervention Type PROCEDURE

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

Conservative

Conservative treatment of a Mallet fracture with a Mallet splint

Group Type ACTIVE_COMPARATOR

Mallet splint

Intervention Type DEVICE

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

Interventions

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Biodegradable Meniscus Arrow®

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

Intervention Type PROCEDURE

Mallet splint

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conmed Linvatec Benelux

OTHER

Sponsor Role lead

Responsible Party

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Dr. D.B. Wouters

Dr. D.B. Wouters

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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st. Elisabeth Hospital

Tilburg, Noord-Barbant, Netherlands

Site Status RECRUITING

Amphia Hospital

Breda, North Brabant, Netherlands

Site Status NOT_YET_RECRUITING

Catharaina Hospital

Eindhoven, North Brabant, Netherlands

Site Status NOT_YET_RECRUITING

Twee Steden Hospital

Tilburg, North Brabant, Netherlands

Site Status RECRUITING

Kennemer Gasthuis Hospital

Haarlem, North Holland, Netherlands

Site Status NOT_YET_RECRUITING

Canisius-Wilhelmina Hospital

Nijmegen, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

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Netherlands

Central Contacts

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D Wouters, MD, PhD

Role: CONTACT

Phone: +31-134655655

Email: [email protected]

FLM Aarts, MD

Role: CONTACT

Phone: +31-639778708

Email: [email protected]

Facility Contacts

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M. Verhofstad, MD,PhD

Role: primary

D de Vos, MD, PhD

Role: primary

A vdVeen, Md, PhD

Role: primary

M Heetveld, Md, PhD

Role: primary

W vd Stappen, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19478891 (View on PubMed)

Other Identifiers

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Mallet2010

Identifier Type: -

Identifier Source: org_study_id