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


- candidate number8244
- NTR NumberNTR2417
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jul-2010
- Secondary IDsU1111-1112-9513 UTN
- Public TitleRadiostereometric analysis as early predictor for aseptic loosening of the tibial component in total knee arthroplasty: A double meta-analysis.
- Scientific TitleRadiostereometric analysis as early predictor for aseptic loosening of the tibial component in total knee arthroplasty: A double meta-analysis
- ACRONYM
- hypothesisThe aim of the meta-analysis is to further investigate the early predictive value of migration measured by RSA 1 year post-operatively for revision for aseptic loosening in TKA and to compose migration thresholds for safe and efficient clinical introduction of new designs.
- Healt Condition(s) or Problem(s) studiedKnee, Arthroplasty , Aseptic loosening, Radio Stereometric Analysis, Tibial component, Migration, Clinical introduction
- Inclusion criteriaRSA studies:
1. Primary Total Knee replacement;
2. Minimal RSA follow-up of 1 year, measuring prosthesis micromotion.

Survival / cohort studies:
1. Primary Total Knee Replacement;
2. Follow up of 5, 10, 15, 20 or 25 years;
3. Endpoint aseptic loosening of tibial:
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. Minimal 75 arthroplasties at baseline.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2008
- planned closingdate31-dec-2010
- 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 tibial component in primary total knee arthroplasty (TKA).
- Primary outcomeRSA studies:
Migration expressed in Maximal Total Point Motion (MTPM) at 1 year in mm.

Survival / cohort studies:
Percentage revision or intended revision for aseptic loosening of the tibial 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 tibial component. Included RSA studies will be matched to included survival studies according to prosthesis, fixation and insert. 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 Knee 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)
- RECORD19-jul-2010 - 30-jul-2010


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