|- candidate number||2115|
|- NTR Number||NTR697|
|- Date ISRCTN created||21-jul-2006|
|- date ISRCTN requested||19-jul-2006|
|- Date Registered NTR||7-jun-2006|
|- Secondary IDs||N/A |
|- Public Title||Closed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures.|
|- Scientific Title||Closed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures; a multicenter randomised controled trial.|
|- hypothesis||Percutaneous, 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) studied||Displaced intra-articular calcaneal fractures|
|- Inclusion criteria||1. 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 criteria||1. A fracture older than 14 days;
2. Grade III open fractures (Gustilo);
3. Patients with chronic substance abuse;
5. Non-ambulant patients;
6. ASA IV-V;
7. Partcipation in an other study.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jul-2006|
|- planned closingdate||1-jul-2013|
|- Target number of participants||150|
|- Interventions||This 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 outcome||The primary outcome measure is the AOFAS score.|
|- Secondary outcome||Secondary 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.|
|- Trial web site||http://www.calcaneus.nl|
|- CONTACT FOR PUBLIC QUERIES||MD. T. Schepers|
|- CONTACT for SCIENTIFIC QUERIES||MD. T. Schepers|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Surgery, Erasmus Medical Center, Medical Ethical Committee (METC)|
(Source(s) of Monetary or Material Support)
|Association Internationale pour L'Ostéosynthèse Dynamique (A.I.O.D.) |
|- Publications||1. 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 summary||Calcaneal 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)|
|- RECORD||7-jun-2006 - 15-jan-2012|