Contact information
Type
Scientific
Primary contact
Dr Dieter Rixen
ORCID ID
Contact details
Department of Trauma/Orthopedic Surgery
University of Witten/Herdecke
c/o Merheim Hospital
Cologne
51109
Germany
+49 (0)22 189 070
RixenD@kliniken-koeln.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2.0 - 07/11/2006
Study information
Scientific title
Randomised controlled trial on risk adapted damage control orthopaedic surgery of femur shaft fractures in multiple trauma patients
Acronym
Study hypothesis
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
University of Cologne, 13/11/2006, ref: 02-109
Study design
Randomised controlled trial without blinding
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/04/2007
Overall trial end date
01/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University of Witten/Herdecke
Cologne
51109
Germany
Sponsor information
Organisation
Private University of Witten/Herdecke gGmbH (Germany)
Sponsor details
Alfred-Herrhausen-Str. 50
Witten
58448
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Deutsche Forschungsgemeinschaft (Germany) (ref: DFG RI 929/3-1)
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
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
Basic results (scientific)
Publication list
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19691847
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26809247
Publication citations
-
Results
Rixen D, Steinhausen E, Sauerland S, Lefering R, Meier M, Maegele MG, Bouillon B, Neugebauer EA, Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients., Trials, 2009, 10, 72, doi: 10.1186/1745-6215-10-72.