Closed Reduction versus Open reduction and internal fixation versus Non-Operative Study of intra-articular calcaneal fractures
| ISRCTN | ISRCTN67665340 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67665340 |
| Protocol serial number | NL637, NTR697 |
| Sponsor | Erasmus Medical Center, Department of Surgery (The Netherlands) |
| Funder | International Association for Dynamic Osteosynthesis (Association Internationale pour L'Ostéosynthèse Dynamique) (A.I.O.D.) |
- Submission date
- 21/07/2006
- Registration date
- 21/07/2006
- Last edited
- 08/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Center Rotterdam
Department of General Surgery and Traumatology
Room-303
PO Box 2040
Rotterdam
3000 CA
Netherlands
| T.Schepers@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Closed Reduction versus Open reduction and internal fixation versus Non-Operative Study of intra-articular calcaneal fractures |
| Study acronym | CRONOS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The primary outcome measure is the American Orthopaedic Foot and Ankle Society (AOFAS) score |
| Key secondary outcome measure(s) |
1. Number of complications (infectious, osseous and osteosynthetic) |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 169 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | 08/01/2021 | Yes | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
