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
  Purpose

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

surgical treatment of distal radius fractures using the locking compression

plate.


Condition Intervention Phase
Distal Radius Fractures
Device: Locking Compression Plate 2,4mm
Device: Locking Compression Plate 3,5mm
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • - Document specific indications for the surgical treatment of distal radius fractures using the LCP

Secondary Outcome Measures:
  • - 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

Enrollment: 450
Study Start Date: December 2001
Study Completion Date: December 2005
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./6m./1y./2y.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205998

Locations
United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02114
Germany
BG-Unfallklinik Ludwigshafen
Ludwigshafen, Germany, 67071
United Kingdom
York District Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
AO Hand Expert Group
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00205998     History of Changes
Other Study ID Numbers: 01-LCP2,4/3,5-03
Study First Received: September 13, 2005
Last Updated: April 26, 2007
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AO Clinical Investigation and Documentation:
Locking Compression Plate
Conservative treatment
Surgical treatment
Radius fractures
AO 23

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 24, 2014