Surgical Plate Osteosynthesis of Distal Radius Fractures

April 26, 2007 updated by: AO Clinical Investigation and Publishing Documentation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ludwigshafen, Germany, 67071
        • BG-Unfallklinik Ludwigshafen
  • United Kingdom
      • York, United Kingdom, YO31 8HE
        • York District Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Document specific indications for the surgical treatment of distal radius fractures using the LCP

Secondary Outcome Measures

Outcome Measure
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

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 (HMS and HSDM)
  • Principal Investigator: Peter G De Boer, F.R.C.S., York District Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2007

Last Update Submitted That Met QC Criteria

April 26, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-LCP2,4/3,5-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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