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All-polyethylene tibial components in TKA in rheumatoid arthritis. A survival analysis up to 20 years.


- candidate number7766
- NTR NumberNTR2218
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-feb-2010
- Secondary IDsU1111-1113-6472  UTN
- Public TitleAll-polyethylene tibial components in TKA in rheumatoid arthritis. A survival analysis up to 20 years.
- Scientific TitleAll-polyethylene tibial components in TKA in rheumatoid arthritis. A survival analysis up to 20 years.
- ACRONYMTotal condylar
- hypothesisAll polyethylene tibial components in total knee arthroplasty in rheumatoid arthritis patients gives durable long term results.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, End stage arthritis of the knee
- Inclusion criteria1. Primary all-polyethylene tibial component total knee arthroplasty;
2. Rheumatoid arthritis;
3. Operation date from 1979-1990;
4. Operation performed in AZL/LUMC Leiden.
- Exclusion criteriaN/A
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-aug-2009
- planned closingdate15-apr-2010
- Target number of participants105
- InterventionsTotal knee arthroplasty.
- Primary outcomeSurvivorship of the all-polyethylene tibial component. Primary outcome is revision for aseptic loosening.
- Secondary outcomeSecondary outcome is revision for other reasons.
- TimepointsFollow-up at 20 years after total knee arthroplasty.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES K.A. Nouta
- CONTACT for SCIENTIFIC QUERIES K.A. Nouta
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryWe will perform a survival analysis up to 20 years of 105 all-polyethylene tibial components in TKA in 81 rheumatoid arthritis. Endpoint is revision of the tibial component.
- Main changes (audit trail)
- RECORD15-feb-2010 - 26-feb-2010


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