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 |
| Secondary identifying numbers | NL637, NTR697 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr T. Schepers
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2006 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 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
University Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center, Department of Surgery (The Netherlands)
University/education
University/education
P.O.Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Research organisation
International Association for Dynamic Osteosynthesis (Association Internationale pour L'Ostéosynthèse Dynamique) (A.I.O.D.)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
