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Femurhead pathology in Sanfilippo disease.


- candidate number12876
- NTR NumberNTR3467
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2012
- Secondary IDsNL39185.018.12 METC AMC
- Public TitleFemurhead pathology in Sanfilippo disease.
- Scientific TitleFemurhead pathology in Sanfilippo disease.
- ACRONYMSanfilippo hip study
- hypothesisThe rationale for the proposed study is the suspicion that a significant number of MPS III patients may experience significant pain and discomfort, and do not receive the appropriate therapy, as due to the lack of communication and loss off cognitive abilities, this diagnosis is overlooked.
- Healt Condition(s) or Problem(s) studiedAvascular femur head necrosis, Femur head pathology, Sanfilippo syndrome (MPS III)
- Inclusion criteriaThe patient should have a biochemically diagnosed MPS III, type A, B or C and should live in the Netherlands.
- Exclusion criteriaThe parent or legal representative is unwilling to participate.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2012
- planned closingdate1-sep-2012
- Target number of participants30
- InterventionsTwo x-rays: X-lauenstein and X-pelvis.
- Primary outcomeWhat is the prevalence of femoral pathology in (Dutch) MPS III patients?
- Secondary outcomeCan the abnormalities be classified using the AVN classification (Herrington?).
Do patients with femoral head pathology have clinical signs and symptoms which may predict the presence of these complications?
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jessica Ruijter, de
- CONTACT for SCIENTIFIC QUERIES Jessica Ruijter, de
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-jun-2012 - 17-jun-2012


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