|- candidate number||8764|
|- NTR Number||NTR2651|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-dec-2010|
|- Secondary IDs||34976.018.10 ABR |
|- Public Title||Amsterdam Wrist Rules in Children, a clinical decision aid.|
|- Scientific Title||Amsterdam Wrist Rules in Children, a clinical decision aid.|
|- ACRONYM||AWR in children|
|- hypothesis||Patients with a wrist trauma represent a substantial part of the patient population at the Emergency Department. Most hospitals routinely carry out a radiological examination of patients following wrist trauma to exclude a distal radius/ulna fracture. However, a large part of x-rays in these patients (50%) do not show a fracture. Consequently, this means a waste of resources, an increase in patient waiting time and unnecessary radiation exposure.
The applicants have developed a clinical decision rule to indicate the need for radiological examination for wrist injuries in children, called the Amsterdam Wrist Rules (AWR). The objective of this study is to evaluate the decrease in requested radiographs in case of a wrist injury with a suspicion of a distal radius fracture. In addition a cost-effectiveness analysis will be performed of direct and indirect medical costs.|
|- Healt Condition(s) or Problem(s) studied||Children, Fracture , Wrist, Diagnostic work-up|
|- Inclusion criteria||Children aged beteen 3-16 years and a history of isloated wrist trauma within 72 h of presentation.|
|- Exclusion criteria||1. Children younger than 3 years old;|
2. Children older than 16 years old;
3. Children who went by radiography (elsewere) before our assesment;
4. Patients with pre-existing musculoskeletal disease, coagulopathy, or delvelopmental delay;
5. Patients with previous histroy of surgery or recent ( <3 months) injury of the affected wrist;
6. Children with multisystem trauma;
7. Clinical suspicion of a scaphoid fracture.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-aug-2012|
|- Target number of participants||1200|
|- Primary outcome||1. The number of applied X-rays in children with acute injury of the wrist after implementation of the AWR;|
2. The number of missed fractures of the distal radius/ulna fracture in children after implementation of the AWR.
|- Secondary outcome||1. The number of X-rays that show a fracture of the distal radius fracture;|
2. Reducing the time that patients with acute wrist injury spent at the ED;
3. Economic analysis.
|- Timepoints||1. Jan- march: Development of clinical decision aid;|
2. April - august: Validation of clinical decision aid.
Primairy outcomes: Timpepoint 2 years;
Secondary outcomes: Timepoint 2 years.
|- Trial web site||http://www.amsterdamwristrules.nl/|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| A. Slaar|
|- CONTACT for SCIENTIFIC QUERIES|| A. Slaar|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Rationale:|
Acute trauma of the wrist is one of the most frequent motives for children visiting the Emergency Department (ED). Generally, these patients are routinely referred for radiological examination. Most X-rays however, do not reveal any fractures. A clinical decision rule concerning the X-ray referral policy may help to select and percolate patients with fractures.
To formulate a clinical decision rule to predict the presence of a distal radius/ulna fracture in children after wrist trauma, presenting to the Emergency Department and to validate this rule in a new population.
Cross sectional, observational diagnostic study.
All consecutive children (age 3-16 year) presenting at the Emergency Department in the participating hospitals with acute wrist trauma.
Main study parameters/endpoints:
Outcome: Distal radius/ulna fracture.
Parameters: Multiple clinical variables which can be assessed on physical examination. These parameters will be described in detail in the methods section.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Any burden or risk for the participating patients additional to standard patient care in not applicable. Clinical examination and X-rays are performed as usual.
|- Main changes (audit trail)|
|- RECORD||12-dec-2010 - 30-jul-2017|