Randomised controlled trial on risk adapted damage control orthopaedic surgery of femur shaft fractures in multiple trauma patients

Conditions

Multiple trauma (including femoral shaft fracture) Injury, Occupational Diseases, Poisoning Trauma

Steinhausen E, Bouillon B, Rixen D, Members of the damage control study group.

2017-12-283 citations

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.

Rixen D, Steinhausen E, Sauerland S, Lefering R, Maegele MG, Bouillon B, Grass G, Neugebauer EAM, and members of the Damage Control Study Group.

2016-01-2522 citations

10.1186/s13063-016-1162-2

Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients.

Rixen D, Steinhausen E, Sauerland S, Lefering R, Meier M, Maegele MG, Bouillon B, Neugebauer EA.

2009-08-1911 citations

10.1186/1745-6215-10-72

Interventions

Experimental intervention: Temporary fixation with fixateur externe and secondary reamed intramedullary nailing not earlier than 48 hours after trauma. Control intervention: Primary reamed nailing

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Maximum SOFA Score within 4 weeks after trauma	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed