|- candidate number||10507|
|- NTR Number||NTR3128|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-nov-2011|
|- Secondary IDs||U1111-1112-9514 UTN|
|- Public Title||Radiostereometric analysis as early predictor for aseptic loosening of the acetabular component in total hip arthroplasty: A double meta-analysis.|
|- Scientific Title||Radiostereometric analysis as early predictor for aseptic loosening of the acetabular component in total hip arthroplasty: A double meta-analysis.|
|- hypothesis||The aim of the meta-analysis is to investigate the early predictive value of migration measured by RSA 2 years post-operatively for revision for aseptic loosening of the acetabular component in THA and to compose migration thresholds for safe and efficient clinical introduction of new designs. |
|- Healt Condition(s) or Problem(s) studied||Arthroplasty , Aseptic loosening, Radio Stereometric Analysis, Migration, Clinical introduction, Hip, Acetabulum|
|- Inclusion criteria||RSA studies:|
1. Primary Total Hip replacement;
2. Minimal RSA follow-up of 1 year, measuring acetabular component migration.
Survival / cohort studies:
1. Primary Total Hip Replacement;
2. Follow up of 5, 10, 15, 20 or 25 years;
3. Endpoint aseptic loosening of acetabular component:
A. For which revision surgery was undertaken;
B. For which revision surgery was indicated, but could not be undertaken (patient decline, poor general health).
4. Survival analysis or % revised due to aseptic loosening on total:
A. Available for specific prosthetic design and fixation;
B. At specific follow up (see point 2).
|- Exclusion criteria||RSA studies:|
1. Non-clinical studies: Animal, experimental set up, phantom.
Survival / cohort studies:
1. Less than 75 arthroplasties at baseline.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-dec-2009|
|- planned closingdate||1-dec-2012|
|- Target number of participants||0|
|- Interventions||This is a systematic review and meta-analysis of migration studies (RSA) and survival / cohort studies (revisions for aseptic loosening) of the acetabular components in primary total hip arthroplasty (THA).|
|- Primary outcome||RSA studies:|
Migration expressed in proximal migration or increase in inclination in the first 2 post-operative year in mm.
|- Secondary outcome||Survival / cohort studies:|
Percentage revision or intended revision for aseptic loosening of the acetabular component at 5 year intervals (e.g. 5 year; 10 year; 15 year et cetera).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. B.G.C.W. Pijls|
|- CONTACT for SCIENTIFIC QUERIES||MD. B.G.C.W. Pijls|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Orthopaedics|
(Source(s) of Monetary or Material Support)
|Atlantic Innovation Fund (Atlantic Canada Opportunities Agency) |
|- Brief summary||This meta-analysis combines early migration from RSA studies with long term revision rates from survival studies for aseptic loosening of the acetabular component. Included RSA studies will be matched to included survival studies according to prosthesis and fixation. Scatter-plots and meta-regression will be used in a sensitivity analysis to evaluate the effect of differences in patient demographics between studies as well as the effect of study quality.|
According to the Swedisch Hip Registry and Australian National Joint Replacement Registry the standard for revision will be set at 3% at 5 years and 5% at 10 years. These standards will be used to determine the migration tressholds (in mm) for the categories: acceptable, at risk and unacceptable.
|- Main changes (audit trail)|
|- RECORD||7-nov-2011 - 14-nov-2011|