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Correctie van verkeerd vastgegroeide onderarmbreuk


- candidate number26712
- NTR NumberNTR6499
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2017
- Secondary IDsMEC-2015-606 Erasmus MC
- Public TitleCorrectie van verkeerd vastgegroeide onderarmbreuk
- Scientific TitleThree-dimensional corrective osteotomy of a malunion after both-bone forearm fracture
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedForearm, Fracture
- Inclusion criteria- Malunion after both-bone forearm fracture
- Pronation or supination <50
- Age > 10 years
- Complaints of the forearm
- Exclusion criteria- Non-anatomic position of the contralateral arm based on congenital or acquired abnormalities;
- Non-anatomic position of the affected arm based on congenital or acquired non-traumatic abnormalities.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 23-aug-2016
- planned closingdate1-jan-2020
- Target number of participants15
- InterventionsThree-dimensional corrective osteotomy of both bones of the forearm with preoperative planning and using patient-specific templates.
- Primary outcome-Postoperative pronation and supination
- Secondary outcome- Postoperative pain relief;
- Postoperative cosmetic improvement;
- Relationship between clinical and radiological outcomes;
- Accuracy of MRI as a planning tool;
- Preoperative MRI for imaging soft tissue scarring;
- Accuracy calculation of true angulation based on preoperative CT and X-rays.
- TimepointsBaseline, 12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.W. Colaris
- CONTACT for SCIENTIFIC QUERIESDr. J.W. Colaris
- Sponsor/Initiator Erasmus Medical Center, Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThe fractura antebrachii (a fracture of both radius and ulna) is one of the most common fractures in children. Fractures with too much displacement are repositioned and stabilized with pens and/or a plaster cast to effect fracture healing. In 30% of the children treated with a plaster cast only, secondary displacement of the fracture occurs. If this displacement is not corrected on time, it can cause a malunion. A malunion can result in pain and functional and cosmetic complaints. A malunion is diagnosed with conventional x-rays and can be showed 3-dimensional by a computer tomography (CT).

A malunion after fractura antebrachii can be improved by a correction osteotomy. In this procedure, the radius and the ulna are re-broken (osteotomy) to restore the anatomy. However, given the complexity of this surgical procedure, many (orthopedic) surgeons are reserved to perform a correction osteotomy of the forearm. With this study, we want to plan the correction osteotomy preoperatively with the help of patient-specific templates based on the unaffected arm using computer models. With this technique, we try to reduce the complexity of the surgery and make the surgery more predictable.
- Main changes (audit trail)
- RECORD16-feb-2017 - 25-jul-2017


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