Status:
COMPLETED
The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Distal Radius Fractures
Poor Bone Quality
Eligibility:
All Genders
50-90 years
Brief Summary
The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open reduction and L...
Detailed Description
Despite fractures of the wrist being widely regarded as "fragility fractures", there is good evidence that they are caused by diminished Bone Mineral Density (BMD) and that a low BMD value predicts a ...
Eligibility Criteria
Inclusion
- Radiologically confirmed closed fracture (within 7 days) of the distal radius
- Primary fracture treatment with a volar LCP 2.4 mm
- Age equal greater 50 and equal younger 90 years
- Willing and able to give written informed consent to participate in the study
- Willing and able to participate in the study follow-ups according to the CIP
- Willing and able to comply with the post-operative management program
- Able to understand and read country national language at an elementary level
Exclusion
- Fracture of ulna (except an associated fracture of the ulnar styloid process)
- Open distal radius fracture
- Concomitant contralateral radius fracture
- Previous distal radius fracture on either side after the age of 25 years
- Time to operation \> 7 days
- Polytrauma
- Regular systemic therapy with corticosteroids due to chronic disease
- Legal incompetence
- Patient received radio- or chemotherapy prior to, during, or within the last year
- Currently active cancer
- Recent history of substance abuse (i.e recreational drugs, alcohol)
- Prisoner
- Currently involved in a pharmaceutical study
- Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01144208
Start Date
February 1 2007
End Date
April 1 2010
Last Update
June 16 2010
Active Locations (11)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Universitätsklinik für Unfallchirurgie
Graz, Styria, Austria, 8036
3
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany, 81675
4
Ev. Diakoniewerk Friederikenstift
Hanover, Lower Saxony, Germany, 30169