Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
21/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.calcaneus.nl

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

Sponsor information

Organisation

Erasmus Medical Center, Department of Surgery (The Netherlands)

Sponsor details

P.O.Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes