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IS SPLINTING FOR STABLE HIP DYSPLASIA NECESSARY IN INFANTS BETWEEN 3 AND 6 MONTHS OF AGE?


- candidate number10874
- NTR NumberNTR3227
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2012
- Secondary IDs08-084/K METC UMCU
- Public TitleIS SPLINTING FOR STABLE HIP DYSPLASIA NECESSARY IN INFANTS BETWEEN 3 AND 6 MONTHS OF AGE?
- Scientific TitleTHE EFFECT OF ABDUCTION TREATMENT ON STABLE DEVELOPMENTAL DYSPLASIA OF THE HIPS IN INFANTS BETWEEN 3 AND 6 MONTHS OF AGE.
- ACRONYMDDH
- hypothesisSPLINTING DOES NOT IMPROVE THE STABLE DYSPLASTIC HIP COMPARED TO NATURAL HISTORY OF THESE HIPS.
- Healt Condition(s) or Problem(s) studiedChildren, Abduction therapy, Hip dysplasia
- Inclusion criteriaINFANTS BETWEEN 3-4 MONTHS WITH STABLE DDH GRAF TYPE IIB EN IIC.
- Exclusion criteria1. NO INFORMED CONSENT;
2. OLDER THAN 4 MONTHS AT TIME OF FIRST VISIT;
3. CO-MORBIDITY;
4. PREVIOUSLY TREATED.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-dec-2008
- planned closingdate31-dec-2013
- Target number of participants100
- InterventionsTHROUGH PROSPECTIVE RANDOMINSATION 50 PATIENTS ARE TREATED WITH ABDUCTION SPLINT (PAVLIK HARNESS) AND 50 PATIENTS WILL RECEIVE SUPERVISED NEGLECT FOLLOW-UP.
AT INTERVALS OF 6 WEEKS TILL THE AGE OF 6 MONTHS, THE CHILDREN ARE SEEN IN CLINIC AND RECEIVE A HIP ULTRASOUND. IN CASE THE HIP ULTRASOUND GETS WORSE, TREATMENT MIGHT BE ADAPTED ACCORDINGLY.
- Primary outcomeALPHA ANGLE ON ULTRASOUND AT INITIAL EXAM, 6 AND 12 WEEKS INTERVALS. (GRAF CLASSIFICATION)
- Secondary outcome1. RESIDUAL DYSPLASIA ON XRAYS;
2. AVN ON XRAYS.
AT 9,12 AND 18 MONTHS OF AGE.
- TimepointsUS OF THE HIPS AT 6 WEEKS INTERVAL FROM THE TIME OF INCLUSION, THUS AT 3 MONTHS, 4,5 MONTHS AND 6 MONTHS OF AGE.
X-RAYS AT 9-12 AND 18 MONTHS.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES R. Sakkers
- CONTACT for SCIENTIFIC QUERIESDr. Virginie Pollet
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Department of Surgery
- PublicationsN/A
- Brief summaryWHAT IS THE NATURAL HISTORY OF STABLE DDH IN THE YOUNG INFANT? IS THERE A PLACE FOR ABDUCTION SPLINTING?
- Main changes (audit trail)
- RECORD6-jan-2012 - 29-sep-2016


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