Metaphyseal Distal Radius Fractures

June 11, 2013 updated by: University Hospital, Clermont-Ferrand

Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.

The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.

The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.

These clinical facts need of course to be validated.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

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

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

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

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
  • age 60 years or older

Exclusion Criteria:

  • open fracture
  • fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
  • polytraumatized patient
  • fractures older than 15 days
  • infection of the operating site
  • previous osseous disease

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
Time Frame: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths
preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths

Secondary Outcome Measures

Outcome Measure
Time Frame
PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)
Time Frame: 2 weeks, 5 weeks, 3, 6 and 12 months
2 weeks, 5 weeks, 3, 6 and 12 months
Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)
Time Frame: 5 weeks, 3, 6 and 12 months
5 weeks, 3, 6 and 12 months
Grip and pinch strength (5 weeks, 3, 6 and 12 months)
Time Frame: 5 weeks, 3, 6 and 12 months
5 weeks, 3, 6 and 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Stryker SA
Polyclinique du Parc Rambot

Investigators

  • Principal Investigator: Stephane Descamps, MD, University Hospital, Clermont-Ferrand

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

June 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0077

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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