Contact information
Type
Scientific
Primary contact
Prof Diana Elbourne
ORCID ID
Contact details
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2629
diana.elbourne@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9312055
Study information
Scientific title
Acronym
The Hip Trial
Study hypothesis
To assess the clinical effectiveness and cost effectiveness of a policy of ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates. In particular the trial will assess whether the reduction in the use of splinting following ultrasound diagnosis is associated with an increased need for late treatment
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Neonatal hip instability
Intervention
Ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates/control.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
X-ray appearance between 12 and 24 months used as a measure of hip function, proportion of babies splinted; proportion of babies needing surgery; financial burden on families and the health services; pyschosocial impact on families
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1994
Overall trial end date
01/01/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Babies less than 6 weeks old with a clinical suspicion of neonatal hip instability
1. Suspicion confirmed by a second doctor
2. There is clinical uncertainty about whether the decision to initiate treatment should be guided by ultrasound examination
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
629
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/1994
Recruitment end date
01/01/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Statistics Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: G9312055)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12504396
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15613565
Publication citations
-
Results
Gardner F, Dezateux C, Elbourne D, Gray A, King A, Quinn A, , The hip trial: psychosocial consequences for mothers of using ultrasound to manage infants with developmental hip dysplasia., Arch. Dis. Child. Fetal Neonatal Ed., 2005, 90, 1, F17-24, doi: 10.1136/adc.2002.025684.
-
Elbourne D, Dezateux C, Arthur R, Clarke NM, Gray A, King A, Quinn A, Gardner F, Russell G, , Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK Hip Trial): clinical and economic results of a multicentre randomised controlled trial., Lancet, 360, 9350, 2009-2017.