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Surgical Plate Osteosynthesis of Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT00205998
Recruitment Status : Terminated (Study completed)
First Posted : September 21, 2005
Last Update Posted : April 27, 2007
Information provided by:

Study Description
Brief Summary:

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

surgical treatment of distal radius fractures using the locking compression


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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)
Study Start Date : December 2001
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. - Primary reduction and maintenance of reduction of the plate fixation
  2. - Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
  3. - Patient and surgeon satisfaction
  4. - Analysis of the occured complications

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205998

United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02114
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
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

ClinicalTrials.gov Identifier: NCT00205998     History of Changes
Other Study ID Numbers: 01-LCP2,4/3,5-03
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

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