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van CCT (UK)


Radiostereometric analysis as early predictor for aseptic loosening of the femoral component in total hip arthroplasty: A double meta-analysis.


- candidate number10508
- NTR NumberNTR3129
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-nov-2011
- Secondary IDsU1111-1112-9515 UTN
- Public TitleRadiostereometric analysis as early predictor for aseptic loosening of the femoral component in total hip arthroplasty: A double meta-analysis.
- Scientific TitleRadiostereometric analysis as early predictor for aseptic loosening of the femoral component in total hip arthroplasty: A double meta-analysis.
- ACRONYM
- hypothesisThe aim of the meta-analysis is to investigate the early predictive value of migration measured by RSA 1 year post-operatively for revision for aseptic loosening of the femoral component in THA and to compose migration thresholds for safe and efficient clinical introduction of new designs.
- Healt Condition(s) or Problem(s) studiedArthroplasty , Aseptic loosening, Radio Stereometric Analysis, Migration, Clinical introduction, Hip, Femoral component
- Inclusion criteriaRSA studies:
1. Primary Total Hip replacement;
2. Minimal RSA follow-up of 1 year, measuring femoral 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 femoral 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 criteriaRSA studies:
1. Non-clinical studies: Animal, experimental set up, phantom.

Survival / cohort studies:
1. Less than 75 arthroplasties at baseline.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-dec-2009
- planned closingdate1-dec-2012
- Target number of participants0
- InterventionsThis is a systematic review and meta-analysis of migration studies (RSA) and survival / cohort studies (revisions for aseptic loosening) of the femoral components in primary total hip arthroplasty (THA).
- Primary outcomeRSA studies:
Migration expressed in subsidence, retroversion or Maximal Total Point Motion (MTPM) in the first 2 post-operative years in mm.

Survival / cohort studies:
Percentage revision or intended revision for aseptic loosening of the femoral component at 5 year intervals (e.g. 5 year; 10 year; 15 year et cetera).
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. B.G.C.W. Pijls
- CONTACT for SCIENTIFIC QUERIESMD. B.G.C.W. Pijls
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
Atlantic Innovation Fund (Atlantic Canada Opportunities Agency)
- PublicationsN/A
- Brief summaryThis meta-analysis combines early migration from RSA studies with long term revision rates from survival studies for aseptic loosening of the femoral 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 Swedish 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 thresholds (in mm) for the categories: acceptable, at risk and unacceptable.
- Main changes (audit trail)
- RECORD7-nov-2011 - 14-nov-2011


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