Research with human participants

Overview of medical research in the Netherlands

5 years after both-bone forearm fractures in children: bony remodeling and functional recovery.

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To define the extent of bony remodeling and functional recovery, 5 years after a both-bone forearm fracture.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational non invasive

ID

NL-OMON41243

Source

ToetsingOnline

Brief title

-geen acroniem-

Condition

  • Other condition

Synonym

Fracture of ulna and radius. Lekenterm: both-bone forearm fracture.

Health condition

Botaandoeningen

Research involving

Human

Sponsors and support

Primary sponsor :
Reinier de Graaf Groep
Source(s) of monetary or material Support :
Indien onderzoeksgeld beschikbaar zal worden.

Intervention

Keyword :
Children, Forearm fracture, Function, Remodeling

Outcome measures

Primary outcome

1. Funcional recovery, 5 years after a both-bone forearm fracture.

2. Bony remodeling: difference in radiological position of union 6 weeks

post-fracture and 5 years post-fracture.

Secondary outcome

1. Functional result in relation tot radiological position of union.

2. Pain and cosmetics, 5 years after a both-bone forearm fracture.

Background summary

Children posses the unique ability to correct a bony deformity. A malunion, is
the result of a fracture. The extent of bony remodeling and funcional recovery
of children after a both-bone forearm fracture mal-union (or antebrachial
fracture) is unclear. Follow-up of the 'Fractura Antebrachii' study is an
oppertunity to define the extent of bony remodeling and functional recovery, 5
years after a both-bone forearm fracture.

Study objective

To define the extent of bony remodeling and functional recovery, 5 years after
a both-bone forearm fracture.

Study design

A prospective follow-up study of a randomised controlled trial.

Study burden and risks

Patients will have to visit the hospital once. They will fill in a two
questionnaires, will undergo physical examination (wrist / forearm function,
grip strength measurement) and two X-ray's.
A risk is the possible adverse effects of X-rays.

Public
Reinier de Graaf Groep

Reinier de Graafweg 3-11
Delft 2625 AD
NL
Scientific
Reinier de Graaf Groep

Reinier de Graafweg 3-11
Delft 2625 AD
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Children (2-11 years)
Elderly (65 years and older)

Inclusion criteria

1. Patients that were included in the Fractura Antebrachii study registered at the METC Zuidwest Holland with number 05-76.
2. Informed consent

Exclusion criteria

1. No inclusion in Fractura Antebrachii study registered at the METC with number 05-76.
2. No informed consent

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
410
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
ClinicalTrials.gov NCT00398242,NCT00314600,NCT00314587,NCT00397995,NCT00397852,NCT00398268
CCMO NL41839.098.12