Status:
COMPLETED
Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures
Lead Sponsor:
Aesculap AG
Conditions:
Thoracic Fracture
Lumbar Fracture
Eligibility:
All Genders
18+ years
Brief Summary
Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are vario...
Eligibility Criteria
Inclusion
- Minimum age of the patients of 18 years
- Indication for operative treatment of fractures of the thoracic or lumbar spine
- Singular A3.1-3 fractures according to the AO classification system
- Declaration of consent in participation in this study and willingness to the treatment according to the study protocol
- Physical and mental ability to meet the clinical and radiological follow-up plan
Exclusion
- Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly
- Additional trauma or fractures of the spine
- Other serious conditions complicating participation in the study
- Systemic or local infections
- Pregnancy or planned pregnancy
- Neurological deficits
- Severe blood coagulation disorders diagnosed preoperatively
- Intake of preoperatively anticoagulants
- Osteoporosis
- Bone metabolism disorders
- Laminectomy necessary during surgery results in exclusion of the patient either
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01810094
Start Date
February 1 2013
End Date
November 1 2016
Last Update
January 26 2017
Active Locations (4)
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1
Vinzenz-Pallotti-Hospital
Bergisch Gladbach, Germany, 51429
2
Universitätsklinik Bonn, Abteilung für Unfallchirurgie
Bonn, Germany, 53127
3
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
Cologne, Germany, 50924
4
Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen
Wermelskirchen, Germany, 42929