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Long term results of Open Reduction and Internal fixation with a volar Locking Compression Plate in the treatment of distal radius fractures.


- candidate number10542
- NTR NumberNTR3146
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2011
- Secondary IDs38835 ABR
- Public TitleLong term results of Open Reduction and Internal fixation with a volar Locking Compression Plate in the treatment of distal radius fractures.
- Scientific TitleLong term results of Open Reduction and Internal fixation with a volar Locking Compression Plate in the treatment of distal radius fractures.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedWrist, Distal radius fracture
- Inclusion criteria1. Distal radius fracture A2-C3;
2. Age > 18jr;
3. Informed Consent.
- Exclusion criteria1. Nerve damage;
2. Multiple treatment;
3. Contralateral distal radius fracture;
4. Death;
5. Follow-up <12 months;
6. Degenerative joint disease;
7. Antebrachii fracture.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 9-jan-2012
- planned closingdate3-feb-2012
- Target number of participants150
- InterventionsN/A
- Primary outcomeDASH (disabilities of arm, shoulder and hand) questionnaire.
- Secondary outcome1. Wrist function (range of movement, wrist squeezing force);
2. Patient satisfaction;
3. Complications;
4. Radiologic parameters;
5. Implant removal.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Sander Paas
- CONTACT for SCIENTIFIC QUERIESDr. W.H. Roerdink
- Sponsor/Initiator Deventer Ziekenhuis, University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Deventer Ziekenhuis
- PublicationsN/A
- Brief summaryAlthough very common (1/6 fractures) the most effective treatment of distal radius fractures still isn't clear. Recent investigations gave promising results of Open Reduction with Internal Fixation (ORIF) with a volar placed Locking Compression Plate (LCP) in the treatment of distal radius fractures. The majority of these studies are limited by a short follow up (12-24 months avarage 18,8) and small numbers of patients (34-305 average 105,8). The long term results of ORIF with a volar LCP remain a question up until this day. This is the reason why we want to investigate long term functional and radiological results after ORIF with a volar LCP. At the Deventer Ziekenhuis (Netherlands) from 2004-2010 a minimum of 150 patients were treated with a volar LCP. We will ask patients to return to our hospital for a one time follow-up visit which includes clinical and radiological investigations.
- Main changes (audit trail)
- RECORD16-nov-2011 - 28-nov-2011


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