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
Protocol serial number	2.0 - 07/11/2006
Sponsor	Private University of Witten/Herdecke gGmbH (Germany)
Funder	Deutsche Forschungsgemeinschaft (Germany) (ref: DFG RI 929/3-1)

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

Department of Trauma/Orthopedic Surgery
University of Witten/Herdecke
c/o Merheim Hospital
Cologne
51109
Germany

Phone	+49 (0)22 189 070
Email	RixenD@kliniken-koeln.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial without blinding
Secondary study design	Randomised controlled trial
Study type	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(s)	Maximum SOFA Score within 4 weeks after trauma
Key secondary outcome measure(s)	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
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/01/2016		Yes	No
Protocol article	protocol	19/08/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/10/2016: Publication reference added.