|- candidate number||7719|
|- NTR Number||NTR2197|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-feb-2010|
|- Secondary IDs||NL30892.058.09 / P09.228 / U1111-1113-6337 ; CCMO / METC LUMC / UTN|
|- Public Title||Predicting aseptic loosening of knee replacement prostheses through innate immunity.|
|- Scientific Title||PRedicting Aseptic Loosening through InnatE immunity.|
|- hypothesis||What 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) studied||Knee, Arthroplasty , Aseptic loosening, Innate immunity, Radio Stereometric Analysis|
|- Inclusion criteria||1. 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 criteria||1. No measurable MTPM at 1 year, or inadequate registration;|
2. Tibia component in frontal plane greater than 5 ° varus or valgus 5.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||80|
|- Primary outcome||1. Maximum Total Point Motion at 1 year, measured by RSA;|
2. PAM3Cys and LPS-stimulated cytokine profiles.
|- Secondary outcome||N/A|
|- Timepoints||Patients will undergo a single venipuncture, to obtain 32ml of blood.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD J.C. Keurentjes|
|- CONTACT for SCIENTIFIC QUERIES||MD J.C. Keurentjes|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Aseptic 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)|
|- RECORD||2-feb-2010 - 17-feb-2010|