Contact information
Type
Scientific
Primary contact
Dr T. Schepers
ORCID ID
Contact details
University Medical Center Rotterdam
Department of General Surgery and Traumatology
Room-303
PO Box 2040
Rotterdam
3000 CA
Netherlands
T.Schepers@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CRONOS
Study hypothesis
Percutaneous, open reduction and internal fixation (ORIF) and conservative treatment of displaced intra-articular calcaneal fractures have a similar outcome as measured with the American Orthopaedic Foot and Ankle Society (AOFAS ) score.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Displaced intra-articular calcaneal fractures (Sanders type II-IV)
Intervention
Patients will be randomised into one of the following groups:
1. The percutaneous, distraction, technique according to Forgon and Zadravecz
2. Open reduction and internal fixation via a lateral approach
3. Conservative treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure is the American Orthopaedic Foot and Ankle Society (AOFAS) score
Secondary outcome measures
1. Number of complications (infectious, osseous and osteosynthetic)
2. Return to work
3. Patient satisfaction (visual analogue scale [VAS])
4. Quality of life (short-form 36 questionnaire [SF36])
5. The need for a secondary arthrodesis
Overall trial start date
01/07/2006
Overall trial end date
01/07/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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. American Society of Anesthesiologists (ASA) IV-V
7. Partcipation in another study
Recruitment start date
01/07/2006
Recruitment end date
01/07/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Research organisation
Funder name
International Association for Dynamic Osteosynthesis (Association Internationale pour L'Ostéosynthèse Dynamique) (A.I.O.D.)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary