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Closed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures.


- candidate number2115
- NTR NumberNTR697
- ISRCTNISRCTN67665340
- Date ISRCTN created21-jul-2006
- date ISRCTN requested19-jul-2006
- Date Registered NTR7-jun-2006
- Secondary IDsN/A 
- Public TitleClosed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures.
- Scientific TitleClosed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures; a multicenter randomised controled trial.
- ACRONYMCRONOS
- hypothesisPercutaneous, ORIF and conservative treated of displaced intra-articular calcaneal fractures have a similar outcome as measured with the AOFAS (American Orthopaedic Foot and Ankle Society) score.
- Healt Condition(s) or Problem(s) studiedDisplaced intra-articular calcaneal fractures
- Inclusion criteria1. All patients, with a displaced intra-articular calcaneal fracture; 2. Between 18 and 70 years old; 3. Compos mentis; 4. Living in the Netherlands; 5. Giving informed consent.
- Exclusion criteria1. A fracture older than 14 days; 2. Grade III open fractures (Gustilo); 3. Patients with chronic substance abuse; 4. Homeless; 5. Non-ambulant patients; 6. ASA IV-V; 7. Partcipation in an other study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate1-jul-2013
- Target number of participants150
- InterventionsThis study will randomise between: 1. the percutaneous, distraction, technique according to Forgon and Zadravecz, 2. Open Reduction and Internal Fixation via a lateral approach, and 3. conservative treatment.
- Primary outcomeThe primary outcome measure is the AOFAS score.
- Secondary outcomeSecondary outcome measures are the number of complications (infectious, osseous and osteosynthetic), returning to work, patient satisfaction (VAS) and quality of life (SF36) and the need for a secondary arthrodesis.
- Timepoints
- Trial web sitehttp://www.calcaneus.nl
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. T. Schepers
- CONTACT for SCIENTIFIC QUERIESMD. T. Schepers
- Sponsor/Initiator Erasmus Medical Center, Department of Surgery, Erasmus Medical Center, Medical Ethical Committee (METC)
- Funding
(Source(s) of Monetary or Material Support)
Association Internationale pour L'Ostéosynthèse Dynamique (A.I.O.D.)
- Publications1. AO-Publishing: Intraarticular calcaneal fractures; operative management. Orthop trauma dir, 2(1): 9-16, 2004. 2. Bridgman, S. A.; Dunn, K. M.; McBride, D. J.; and Richards, P. J.: Interventions for treating calcaneal fractures. Cochrane Database Syst Rev, (2): CD001161, 2000. 3. Randle, J. A.; Kreder, H. J.; Stephen, D.; Williams, J.; Jaglal, S.; and Hu, R.: Should calcaneal fractures be treated surgically? A meta-analysis. Clin Orthop, (377): 217-27, 2000.
- Brief summaryCalcaneal fractures are a disabling injury and optimal treatment has yet to be determined. Three meta-analyses1-3 on four RCT’s, one prospective cohort study and three retrospective studies showed a trend towards overall improved outcome in patients treated with Open Reduction and Internal Fixation (ORIF), but most studies were clearly powered for specific outcomes and used non-comparable outcome scores. The outcome after percutaneous treatment has not been studied in a randomised trial. Considering the above there is a need for a level-2 study comparing the different treatment modalities of ORIF, percutaneous treatment and conservative treatment, which is adequately powered to the most cited disease-specific outcome score: the American Orthopaedic Foot and Ankle Society Hindfoot Score (AOFAS). This study aims to demonstrate a clinically significant difference of 20 points using the most cited and clinically relevant American Orthopedic Foot and Ankle Society hindfoot score (total 100 points) after 2 and 5 years. ORIF, percutaneous reduction and fixation and conservatively treated patients will be compared in an adequately powered, multicenter randomized controlled trial with 3 treatment arms. Clinical outcome will be measured using the AOFAS score, standard physical exam and radiographic criteria after 2 and 5 years.
- Main changes (audit trail)
- RECORD7-jun-2006 - 15-jan-2012


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