The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
Completed
Conditions studied: Distal Radius Fractures, Poor Bone Quality, Treatment Complications
In brief
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 Locking Compression Plates(LCP).
Key facts
- Study ID
- NCT01144208
- Run by
- AO Clinical Investigation and Publishing Documentation
- People needed
- 244
- Starts
- 2007-02-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2010-06-16
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Universitätsklinik für Unfallchirurgie — Graz, Styria, Austria
- Klinikum rechts der Isar der TU Muenchen — Munich, Bavaria, Germany
- Ev. Diakoniewerk Friederikenstift — Hanover, Lower Saxony, Germany
- Campus Virchow-Klinikum, Charité — Berlin, State of Berlin, Germany
- C.T.O. Azienda Ospedaliera Careggi — Florence, Tuscany, Italy
- Singapore General Hospital — Singapore, Singapore, Singapore
- Universitätsspital Basel — Basel, Basel, Switzerland
- Kantonsspital — Lucerne, Canton of Lucerne, Switzerland
- Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland
- Stadtspital Triemli — Zurich, Canton of Zurich, Switzerland
Full record on ClinicalTrials.gov
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