No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Intervention
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.
Department of General Surgery and Traumatology,
Room-303,
PO Box 2040
T. Schepers
Rotterdam 3000 CA
The Netherlands
T.Schepers@erasmusmc.nl
Department of General Surgery and Traumatology,
Room-303,
PO Box 2040
T. Schepers
Rotterdam 3000 CA
The Netherlands
T.Schepers@erasmusmc.nl
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;
4. Homeless;
5. Non-ambulant patients;
6. ASA IV-V;
7. Partcipation in an other study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL637 |
| NTR-old | NTR697 |
| Other | : N/A |
| ISRCTN | ISRCTN67665340 |
Summary results
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.