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Predicting aseptic loosening of knee replacement prostheses through innate immunity.


- candidate number7719
- NTR NumberNTR2197
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2010
- Secondary IDsNL30892.058.09 / P09.228 / U1111-1113-6337 ; CCMO / METC LUMC / UTN
- Public TitlePredicting aseptic loosening of knee replacement prostheses through innate immunity.
- Scientific TitlePRedicting Aseptic Loosening through InnatE immunity.
- ACRONYMPRALINE
- hypothesisWhat does the non-specific cytokine response contribute to the prediction of prosthesis fixation (expressed in MTPM after 1 year), compared with simple patient characteristics?
- Healt Condition(s) or Problem(s) studiedKnee, Arthroplasty , Aseptic loosening, Innate immunity, Radio Stereometric Analysis
- Inclusion criteria1. Patients over 18 years, who underwent elective knee replacement arthroplasty;
2. Patients who are part of an RSA-cohort and whose MTPM at 1 year have been measured.
- Exclusion criteria1. No measurable MTPM at 1 year, or inadequate registration;
2. Tibia component in frontal plane greater than 5 varus or valgus 5.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2010
- planned closingdate1-mrt-2012
- Target number of participants80
- InterventionsN/A
- Primary outcome1. Maximum Total Point Motion at 1 year, measured by RSA;
2. PAM3Cys and LPS-stimulated cytokine profiles.
- Secondary outcomeN/A
- TimepointsPatients will undergo a single venipuncture, to obtain 32ml of blood.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD J.C. Keurentjes
- CONTACT for SCIENTIFIC QUERIESMD J.C. Keurentjes
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- PublicationsN/A
- Brief summaryAseptic loosening is the most common cause of failure of current joint replacement arthroplasties in the long term (>10 years after index surgery). Wear particles cause a sterile periprosthetic inflammatory process, which leads to osteolysis and formation of fibrous tissue. Pro-inflammatory cytokines play a major role in this process.
Micromotion preceeds aseptic loosening and can be accurately measured by RSA. RSA measurements can only be performed if tantalum markers are inserted during surgery.
Innate immunity can be determined at any time, even pre-operatively. Innate immunity may even be a useful tool in predicting the preoperative risk of aseptic loosening.
- Main changes (audit trail)
- RECORD2-feb-2010 - 17-feb-2010


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