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A Randomized Controlled Trial of the Treatment of Mallet Fractures

Primary Purpose

Mallet Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Biodegradable Meniscus Arrow®
Mallet splint
Sponsored by
Conmed Linvatec Benelux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mallet Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • st. Elisabeth HospitalRecruiting
  • Amphia Hospital
  • Catharaina Hospital
  • Twee Steden HospitalRecruiting
  • Kennemer Gasthuis Hospital
  • Canisius-Wilhelmina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Operative

Conservative

Arm Description

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

Conservative treatment of a Mallet fracture with a Mallet splint

Outcomes

Primary Outcome Measures

Extension deficit
To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.
extension deficit
at every visit, the extension in the DIP joint, is measured

Secondary Outcome Measures

wound healing disturbances
at every control, this is noted

Full Information

First Posted
October 31, 2010
Last Updated
August 17, 2012
Sponsor
Conmed Linvatec Benelux
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1. Study Identification

Unique Protocol Identification Number
NCT01232426
Brief Title
A Randomized Controlled Trial of the Treatment of Mallet Fractures
Official Title
A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Conmed Linvatec Benelux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mallet Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Experimental
Arm Description
operative treatment of a Mallet fracture with a biodegradable Meniscus Arrow®
Arm Title
Conservative
Arm Type
Active Comparator
Arm Description
Conservative treatment of a Mallet fracture with a Mallet splint
Intervention Type
Procedure
Intervention Name(s)
Biodegradable Meniscus Arrow®
Intervention Description
Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®
Intervention Type
Device
Intervention Name(s)
Mallet splint
Intervention Description
Conservative treatment of the Mallet fracture with the traditional Mallet splint.
Primary Outcome Measure Information:
Title
Extension deficit
Description
To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.
Time Frame
1 year
Title
extension deficit
Description
at every visit, the extension in the DIP joint, is measured
Time Frame
1 year
Secondary Outcome Measure Information:
Title
wound healing disturbances
Description
at every control, this is noted
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
nail deformaties
Description
at every control nail deformaties, if present, are noted
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
D Wouters, MD, PhD
Phone
+31-134655655
Email
dwouters@tsz.nl
First Name & Middle Initial & Last Name or Official Title & Degree
FLM Aarts, MD
Phone
+31-639778708
Email
flmaarts@gmail.com
Facility Information:
Facility Name
st. Elisabeth Hospital
City
Tilburg
State/Province
Noord-Barbant
ZIP/Postal Code
5022GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Verhofstad, MD,PhD
First Name & Middle Initial & Last Name & Degree
M Verhofstad, MD, PhD
Facility Name
Amphia Hospital
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818CK
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D de Vos, MD, PhD
Facility Name
Catharaina Hospital
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623EJ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A vdVeen, Md, PhD
Facility Name
Twee Steden Hospital
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5042AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fenne Aarts, MD
Facility Name
Kennemer Gasthuis Hospital
City
Haarlem
State/Province
Noord-Holland
ZIP/Postal Code
2035RC
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Heetveld, Md, PhD
Facility Name
Canisius-Wilhelmina Hospital
City
Nijmegen
ZIP/Postal Code
6532SZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W vd Stappen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19478891
Citation
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.
Results Reference
background

Learn more about this trial

A Randomized Controlled Trial of the Treatment of Mallet Fractures

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