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Pre operatieve navigatie voor de plaatsing van een totale knie prothese. Wat doet de industrie?


- candidate number19295
- NTR NumberNTR4739
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-aug-2014
- Secondary IDs13N09 13.007
- Public TitlePre operatieve navigatie voor de plaatsing van een totale knie prothese. Wat doet de industrie?
- Scientific TitlePatient specific matched guides for total knee arthroplasty: A single surgeon experience with different systems
- ACRONYM
- hypothesisThere is no difference between the different PSG systems if it becomes to outliers of the biomechanical axis
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Alignment
- Inclusion criteria- eligible for primary unilateral TKA
- able and willing to participate
- written consent
- Exclusion criteriaPatients who were not eligible to undergo MRI due to metal artefacts around the knee joint from previous surgery, claustrophobia, movement artefacts during MRI scanning time, pigmented villonodular synovitis (PVNS), implanted electronic devices (e.g. pacemaker, neurostimulator for bladder control or cochlear implants).
Patients that refused to consent were excluded.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2016
- Target number of participants105
- InterventionsPSG from the following manufaturer
TruMatch system
Visionaire system
Patient Specific Instrument system
Signature system
- Primary outcomePre operative approved planning for the femur and tibia component were compared with the post operative achieved alignment of each component on radiographs.
Biomechanical limb alignment and implant position were measured with a calibrated protocol on digital images on a PACS system [Boonen et al 2012,Boonen et al 2013]. Biomechanical axis (HKA: Hip-Knee-Ankle angle) was evaluated on standardized 1-year postoperative coronal full leg standing radiographs. Varus/ valgus position of the femur (FFC) and tibia (FTC) components perpendicular to the HKA angle were measured on the same coronal radiographs.
- Secondary outcomeFlexion/ extension of the femur component (LFC), measured from the anterior femoral cortex and posterior or anterior slope of the tibia component (LTC) measured from the posterior cortex of the tibia, were evaluated on 1-year postoperative lateral radiographs. Deviations >3 degrees between pre-operative planned HKA (sum of FFC and FTC) and individual components (FFC, FTC, LFC and LTC) compared to post operative achieved alignment on radiographs, were considered as outliers.
- TimepointsPre-, 6 weeks and 12 monts post-operative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsSchotanus, Martijn GM, Bert Boonen, and Nanne P. Kort. "Patient specific guides for total knee arthroplasty are ready for primetime." World Journal of Orthopedics 7.1 (2016): 61.
- Brief summary
- Main changes (audit trail)
- RECORD13-aug-2014 - 20-feb-2016


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