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van CCT (UK)

van CCT (UK)

Patients Prospectively Recruited in Knee and Hip Arthroplasty.

- candidate number7712
- NTR NumberNTR2190
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2010
- Secondary IDsNL29018.058.09 / P09.189 / U1111-1113-6244 ; CCMO / METC / UTN
- Public TitlePatients Prospectively Recruited in Knee and Hip Arthroplasty.
- Scientific TitlePAtients Prospectively Recruited In Knee and hip Arthroplasty.
- hypothesis1. What are the determinants of quality of life of hip and knee replacement arthroplasty at long term follow-up?
2. Which genetic factors are associated with aseptic loosening in hip and knee replacement arthroplasty?
3. Which genetic determinants predispose to hip or knee replacement arthroplasty due to osteoarthritis?
- Healt Condition(s) or Problem(s) studiedQuality of life, Hip-knee replacement, Genetics, Illness perception, Aseptic loosening
- Inclusion criteriaThe study population consists of 3000 patients, who underwent hip or knee replacement, and were prospectively recruited in 2 previous studies (Trigger-study and TOMaat-study). We will extend the follow-up of these patients from 1-5 years postoperatively until revision hip or knee surgery takes place.
- Exclusion criteriaNone.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2009
- planned closingdate1-jan-2025
- Target number of participants3000
- InterventionsN/A
- Primary outcomeAseptic loosening.
- Secondary outcomeQuality of life.
- TimepointsPatients will be sent questionnaires on Quality of Life every year, until revision hip or knee surgery takes place.

Questionnaires used are: Oxford Hip Score, Oxford Knee Score, HOOS, KOOS, Squash, EQ-5D, SF-36, IPQ en comorbiditeit according to CBS.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Arthritis Association (Reumafonds)
- PublicationsN/A
- Brief summaryHip and knee replacement arthroplasties relieve pain and improve physical functioning and quality of life. However, some patients suffer from persisting pain or are not satisfied with the outcome. Several studies have suggested risk factors for poor outcome after hip and knee replacement arthroplasty; however, most studied cohorts are relatively small (n<800), which makes correcting for confounding factors problematic. This larger cohort (n=3000) enables us to study all suggested risk factors and the possible correlations between them, while correcting for confounding factors. By determining risk factors for poor outcome after hip and knee replacement arthroplasty, it will be possible to influence these factors, in order to optimalise the outcome of hip and knee replacement arthroplasty.

Aseptic loosening is the main cause of failure of hip and knee replacement arthroplasty in the long term. Several studies have suggested variances in immunomodulating genes as a possible contributor to aseptic loosening; however, group sizes were too small to draw any firm conclusions (n<90). In this current study, we aim to study the influence of immunomodulating genes on aseptic loosening in a larger patient cohort (n=3000) A better understanding of the underlying process of aseptic loosening will make it possible to determine the prognosis of prosthesis loosening more accurately.

Osteoarthritis is the most frequent indication for hip and knee arthroplasty. Conversely, the indication for hip and knee replacement arthroplasty can be viewed as the final stage in the pathophysiology of osteoarthritis. Recent studies showed that genetics play an important role in the pathophysiology of osteoarthritis. By comparing genetic variations between patients in final stage osteoarthritis and matched controls with a less severe clinical manifestation of osteoarthritis, a better understanding of the pathophysiology of osteoarthritis can be obtained.
- Main changes (audit trail)
- RECORD1-feb-2010 - 14-feb-2010

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