Status:
TERMINATED
Surgical Plate Osteosynthesis of Distal Radius Fractures
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Collaborating Sponsors:
Synthes Inc.
AO Hand Expert Group
Conditions:
Distal Radius Fractures
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.
Detailed Description
In addition the differences between the surgical treatment compared to conservative treatment with respect to fracture healing, functional outcome and subject satisfaction will be analysed after 6w....
Eligibility Criteria
Inclusion
- skeletally mature female and male
- Distal radius and ulnar fractures AO 23
- 10 days after injury
Exclusion
- general or local conditions adversely affecting the bone physiology
- ISS \>16
- osteosynthesis close to the wrist joint where a different implant has been used
- history of drug and alcohol abuse
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00205998
Start Date
December 1 2001
End Date
December 1 2005
Last Update
April 27 2007
Active Locations (3)
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1
Harvard Medical School
Boston, Massachusetts, United States, 02114
2
BG-Unfallklinik Ludwigshafen
Ludwigshafen, Germany, 67071
3
York District Hospital
York, United Kingdom, YO31 8HE