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Pseudotumors in ceramic-on-polyethylene hip prosthesis.


- candidate number14231
- NTR NumberNTR3797
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jan-2013
- Secondary IDs 
- Public TitlePseudotumors in ceramic-on-polyethylene hip prosthesis.
- Scientific TitlePrevalence of pseudotumours after total hip arthroplasty. A cross sectional clinical study.
- ACRONYM
- hypothesisTo asses the proportion of patients with pseudotumor observerd on MARS-MRI images.
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Pseudotumor, Ceramic-on-polyethylene
- Inclusion criteria1. Non-revised, unilateral Mallory-Head total hip arthroplasty with a ceramic on polyethylene bearing;
2. Willing to undergo one MRI scan.
- Exclusion criteria1. Any hip revision surgery;
2. Not willing to participate.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-feb-2013
- planned closingdate15-apr-2013
- Target number of participants50
- InterventionsBlood serum sample of Chrome and Cobalt.
- Primary outcomePrevalence of pseudotumors.
- Secondary outcomeCorrelation of pseudotumors with serum ion levels.
- TimepointsSingle observation.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. W. Weegen, van der
- CONTACT for SCIENTIFIC QUERIESDrs. W. Weegen, van der
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Biomet
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD20-jan-2013 - 29-jan-2013


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