Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/01/2007
Date assigned
09/02/2007
Last edited
13/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.uni-wh.de/

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

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19691847
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26809247

Publication citations

  1. 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.

Additional files

Editorial Notes

13/10/2016: Publication reference added.