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

Completed

• Conditions: Multiple trauma (including femoral shaft fracture); Injury, Occupational Diseases, Poisoning; Trauma

• Registration Number: ISRCTN10321620
• Lead Sponsor: Private University of Witten/Herdecke gGmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-09
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified