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2D vs 3D uitlining van een totale knie prothese


- candidate number26665
- NTR NumberNTR6434
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2017
- Secondary IDs17N11 METC 2017007 BWO
- Public Title2D vs 3D uitlining van een totale knie prothese
- Scientific TitleProspective analysis of Patient-specific matched instruments comparing x-ray- (2-D) with MRI (3-D) based reconstructed preoperative templates of the knee joint for total knee arthroplasty
- ACRONYM2D3DPSI
- hypothesisPreoperative planning with x-ray-based PSI have comparable outcome as 3D used MRI-based PSI resulting in indirectly reduced costs on storage of implants and instruments.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Total knee arthroplasty
- Inclusion criteriao MRI based PSG
- Exclusion criteriao CT based PSG
o Surgeries primary done by a resident
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate1-sep-2017
- Target number of participants25
- InterventionsPSI base on x-ray
- Primary outcomeTo demonstrate that x-ray based-PSI can be used as template modality to predict the actual size of both the tibial and femoral component sizes as used intraoperatively with MRI-based PSMI, with the aim to reduce costs.
- Secondary outcomeNumber of adjustments will be calculated for both the X-ray and MRI-based templates
o the preoperative plan before approval
o the approved plan during surgery
o the default plan during surgery
o predicted sizes correctly by the software.
o predicted sizes correctly with an error of 1 size
- TimepointsPre and perioperative
- 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 summaryResults in literature on the topic of size prediction vary with authors reporting good accuracy of the PSI to predict component size and others reporting frequent intraoperative directed changes. This industry driven intervention aims to reduce hospital costs. Although, results on this topic are inconclusive. Recently, 2D PSMI models are developed. These models can save money since a MRI is not necessary. With the use of x-rays of the knee joint, 2D PSMI guides can be manufactured.
- Main changes (audit trail)
- RECORD9-feb-2017 - 29-jun-2017


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