Surgical Plate Osteosynthesis of Distal Radius Fractures

This study has been terminated.
(Study completed)
Sponsor:
Collaborators:
Synthes Inc.
AO Hand Expert Group
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00205998
First received: September 13, 2005
Last updated: April 26, 2007
Last verified: April 2007

September 13, 2005
April 26, 2007
December 2001
Not Provided
- Document specific indications for the surgical treatment of distal radius fractures using the LCP
Same as current
Complete list of historical versions of study NCT00205998 on ClinicalTrials.gov Archive Site
  • - Primary reduction and maintenance of reduction of the plate fixation
  • - Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
  • - Patient and surgeon satisfaction
  • - Analysis of the occured complications
Same as current
Not Provided
Not Provided
 
Surgical Plate Osteosynthesis of Distal Radius Fractures
Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)

Primary objective of the study is to demonstrate specific indications for the

surgical treatment of distal radius fractures using the locking compression

plate.

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./6m./1y./2y.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Distal Radius Fractures
  • Device: Locking Compression Plate 2,4mm
  • Device: Locking Compression Plate 3,5mm
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
450
December 2005
Not Provided

Inclusion Criteria:

  • skeletally mature female and male
  • Distal radius and ulnar fractures AO 23
  • 10 days after injury

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   United Kingdom
 
NCT00205998
01-LCP2,4/3,5-03
No
Not Provided
AO Clinical Investigation and Documentation
  • Synthes Inc.
  • AO Hand Expert Group
Principal Investigator: Andreas W Wentzensen, Prof. MD BG-Unfallklinik Ludwigshafen
Principal Investigator: Jesse B Jupiter, Prof. MD Harvard Medical School
Principal Investigator: Peter G De Boer, F.R.C.S. York District Hospital
AO Clinical Investigation and Documentation
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP