|- candidate number||8517|
|- NTR Number||NTR2544|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-okt-2010|
|- Secondary IDs||NL34430 METC AMC|
|- Public Title||Amsterdam Wrist Rules (AWR).|
|- Scientific Title||Amsterdam Wrist Rules: A study to develop Clinical Decision Rules for the use of Radiography in Acute wrist injuries.|
|- 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 fracture. However, a large part of x-rays in these patients (45%) do not show a fracture. Consequently, this means a waste of resources, an increase in patient waiting time and unnecessary radiation exposure. In a large training hospital the yearly costs of unnecessary X-rays performed are estimated on € 85.900,-.|
The applicants have developed a clinical decision rule to indicate the need for radiological examination for wrist injuries, 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||Adults, Wrist, Acute injury|
|- Inclusion criteria||1. Every patient with acute injury of the wrist;|
2. 18 years and older of age.
|- Exclusion criteria||1. Neurological alterations in upper limbs;|
2. Pain in elbow or in ipsilateral forearm;
3. Patients with x-rays from another hospital;
4. Multiple trauma;
5. Patients already treated in another hospital;
6. intense pain of deformity preventing patient physical examination.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-nov-2010|
|- planned closingdate||1-nov-2012|
|- Target number of participants||2000|
|- Interventions||Amsterdam Wrist Rules.|
|- Primary outcome||1. The number of applied X-rays in adult patients with acute injury of the wrist after implementation of the AWR;|
2. The number of missed fractures of the distal radius fracture in adult patients 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||Primairy outcomes: Timpepoint 2 years;|
Secondary outcomes: Timepoint 2 years.
|- Trial web site||www.amsterdamwristrules.com|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD Abdelali Bentohami|
|- CONTACT for SCIENTIFIC QUERIES||MD Abdelali Bentohami|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||The incidence of wrist fractures is 400/100.000 in the Netherlands. These types of fractures represent an important amount of the workload in the Emergency Department. There are indications that in patients with wrist trauma most radiological examinations performed are redundant. We present a study whose aim is to develop a clinical decision rule called Amsterdam Wrist Rules (AWR). This decision should helps to determine when an X-ray of the wrist is indicated. After development of the rule the effectiveness of the AWR will be evaluated by attaining two different aims:|
1. Is there a decrease in the number of requested X-rays of the wrist after introduction of the AWR?
2. How many fractures of the wrist are missed after introduction of the AWR?
In a subsequent study a cost analysis and a satisfaction survey will be carried out.
|- Main changes (audit trail)|
|- RECORD||1-okt-2010 - 14-feb-2016|