Randomised controlled trial on risk adapted damage control orthopaedic surgery of femur shaft fractures in multiple trauma patients
| ISRCTN | ISRCTN10321620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10321620 |
| Secondary identifying numbers | 2.0 - 07/11/2006 |
- Submission date
- 05/01/2007
- Registration date
- 09/02/2007
- Last edited
- 13/10/2016
- 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 Dieter Rixen
Scientific
Scientific
Department of Trauma/Orthopedic Surgery
University of Witten/Herdecke
c/o Merheim Hospital
Cologne
51109
Germany
| Phone | +49 (0)22 189 070 |
|---|---|
| RixenD@kliniken-koeln.de |
Study information
| Study design | Randomised controlled trial without blinding |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Randomised controlled trial on risk adapted damage control orthopaedic surgery of femur shaft fractures in multiple trauma patients |
| Study objectives | Primary reamed nailing of femoral shaft fracture versus temporary fixation with fixateur externe and secondary reamed intramedullary nailing (not earlier than 48 hours after trauma) are different in maximum Sepsis-related Organ Failure (SOFA) score within four weeks after trauma. |
| Ethics approval(s) | University of Cologne, 13/11/2006, ref: 02-109 |
| Health condition(s) or problem(s) studied | Multiple trauma (including femoral shaft fracture) |
| Intervention | Experimental intervention: Temporary fixation with fixateur externe and secondary reamed intramedullary nailing not earlier than 48 hours after trauma. Control intervention: Primary reamed nailing of femoral shaft fracture. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Maximum SOFA Score within 4 weeks after trauma |
| Secondary outcome measures | 1. Hospital mortality 2. Cumulative organ failure = sum of SOFA score points for the first 28 days 3. Acute Respiratory Distress Syndrome (ARDS) incidence 4. Systemic Inflammatory Response Syndrome (SIRS) and sepsis incidence during Intensive Care Unit (ICU) stay 5. Quantity and duration of surgical interventions, anaesthetics and costs of surgery (material, time) 6. Length of ICU stay, number of ventilator free days 7. Therapeutic Intervention Scoring System (TISS) 28 during ICU (costs) 8. Rate of phlegmona of the medullary cavity 9. Patient rate in which conversion to internal fixation was not possible 10. Rate of pseudarthrosis 11. Functional outcome at discharge, six and 12 months after trauma 12. Quality of life at discharge, six and 12 months after trauma (determined by Polytrauma Outcome [POLO] chart) 13. Glasgow Outcome Scale (GOS) at discharge, six and 12 months after trauma 14. Length of hospital stay 15. Length of inability to work |
| Overall study start date | 01/04/2007 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 |
| Key inclusion criteria | 1. Multiple trauma (injury of at least two body regions) 2. Injury Severity Score (ISS) more than 16 3. Femoral shaft fracture which can be treated in principle by nail or fixateur externe 4. Beginning of surgical treatment within 24 hours after trauma 5. Patient aged 18 years and older 6. Calculated probability of death between 20% and 60% 7. All factors known which are needed for the calculation of probability of death (age, ISS, Glasgow Coma Score [GCS], base excess, quick) |
| Key exclusion criteria | 1. III° open fractures 2. Endangerment of the patient by one of the both strategies 3. Refusal of one of both strategies by either the investigator or the patient 4. Start of internal or external fracture fixation before randomisation 5. Participation in concurrent interventional trials 6. Pregnancy |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Witten/Herdecke
Cologne
51109
Germany
51109
Germany
Sponsor information
Private University of Witten/Herdecke gGmbH (Germany)
University/education
University/education
Alfred-Herrhausen-Str. 50
Witten
58448
Germany
| Website | http://www.uni-wh.de/ |
|---|---|
"ROR" |
https://ror.org/00yq55g44 |
Funders
Funder type
Government
Deutsche Forschungsgemeinschaft (Germany) (ref: DFG RI 929/3-1)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/08/2009 | Yes | No | |
| Results article | results | 25/01/2016 | Yes | No |
Editorial Notes
13/10/2016: Publication reference added.
