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Kwaliteit van leven na plaatsing van een knie prothese bij dag-opname.


- candidate number26674
- NTR NumberNTR6406
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2017
- Secondary IDs16N194 METC 
- Public TitleKwaliteit van leven na plaatsing van een knie prothese bij dag-opname.
- Scientific TitleHealth-Related Quality of Life after Knee Arthroplasty following an outpatient surgery pathway: a prospective observational comparative case study.
- ACRONYMHRQ-TKA_OS
- hypothesisIt was hypothesized that there would be no difference in quality of life between both pathways.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Arthroplasty
- Inclusion criteriao Operated between June 2014 and June 2015
o Elective primary knee arthroplasty
- Exclusion criteriao Incomplete registration of data
o Acute or revision arthroplasty surgery
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate1-jun-2017
- Target number of participants361
- Interventionsenhanced recovery pathway
outpatient joint arthroplasty
- Primary outcomeHealth-Related Quality of Life
- Secondary outcomeother PROMs:
Oxford Knee Score (OKS; 12 to 60, 12 being the best outcome) [Haverkamp et al. 2005] and the Western Ontario and McMaster Universities Arthritis Index (WOMAC; 0 to 100, 100 being the best outcome) [Roorda et al. 2004]. Experienced pain was measured by a Numerical Rating Scale (NRS, 0 to 10, 10 being ‘worst pain’).
- Timepointspreoperative, 3- and 12-months postoperative
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryModification of a selected number of literature-based protocols, used together, can be implemented in a care pathway. Such optimization is also known as ‘outpatient joint arthroplasty’, a multimodal clinical pathway based on well-defined patient selection criteria.
With the present case-controlled study, we want to analyze if the OS pathway will result in comparable or better outcomes compared to our standard pathway (ERP) if it becomes to Health-Related Quality of Life as measured with the EQ-5D PROMs.
- Main changes (audit trail)
- RECORD9-feb-2017 - 29-jun-2017


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