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A comparison of calibration methods when templating fot total hip replacements


- candidate number15192
- NTR NumberNTR4092
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2013
- Secondary IDs13-N-93 METC Atrium-Orbis-Zuyd
- Public TitleA comparison of calibration methods when templating fot total hip replacements
- Scientific TitleA comparison of calibration methods when templating fot total hip replacements
- ACRONYMN/A
- hypothesisIs the double marker technique superior to the other calibration techniques in digital radiography when templating for total hip replacements. Comparison of four systems for calibration when templating for total hip replacement with digital radiography. In this trial we are investigating the accuracy of the double marker technique next to our gold standard, the fixed magnification
- Healt Condition(s) or Problem(s) studiedMagnification, Hip replacement, Templating, Calibration, Digital Radiology
- Inclusion criteriaPatients who are referred for a routine radiograph of the hip prothesis. Patient must have a hip prothesis with a known size of the femoral head. The femoral head has to be measurable on the digital radiograph.
- Exclusion criteriaHip prothesis with a femoral head that is not measurable or not known.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 10-aug-2013
- planned closingdate31-dec-2013
- Target number of participants30
- InterventionsN/A
- Primary outcomeComparison of four systems for calibration when templating for total hip replacement with digital radiography. In this trial we are investigating the accuracy of the double marker technique next to our gold standard, the fixed magnification. Also the results of the measured magnification (per patient) and single marker technique are included and compared.
- Secondary outcomeInterobserver-variation for each method
- TimepointsAnalyses will be performed during the trial and after the inclusion of patients is finished.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Junghans
- CONTACT for SCIENTIFIC QUERIES M. Junghans
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsN/A
- Brief summaryAccurate pre-operative planning for total hip replacement requires that the magnification of the radiograph is known. Prior to the introduction of digital radiographs, templating of hip replacement was performed using transparent templates of fixed magnification. These templates are not suitable for digital images, as the size of the on-screen image varies with the dimension of the monitor used, and can be enlarged or reduced on screen. When using digital radiographs the most widely used method of calculating radiological magnification is to place a marker at time the radiograph is taken. The marker must be located as close to the hip joint as possible so that the magnification can be calculated. This single marker method is known to have a large error mostly due to malpositioning.
A novel approach is the double marker technique. This method uses two separate radiological markers: one behind the pelvis and the other in front, as the patient lies supine.
Via the software that comes with this new device, with the name KingMark, the magnification can be calculated. An article written by King J et al, tells us that the double marker technique is superior to the single marker technique. However, in an other study done by Franken et al. the single marker technique was compared with fixed magnification and was shown to have large errors. So the double marker technique has been compared with the single marker technique that is known to have large errors. In our study we want to compare the double marker technique with our gold standard and that is the fixed magnification.
- Main changes (audit trail)
- RECORD24-jul-2013 - 9-aug-2013


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