Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

March 12, 2014 updated by: Sari Ponzer, Karolinska Institutet

Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board

Study Type

Interventional

Enrollment (Actual)

70

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

  • Sweden
      • Stockholm, Sweden, 118 83
        • Stockholm South Hospital Department of Orthopeadic Surgery

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

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female 50-74 years or male 60-74 years
  • Dorsally displaced extraarticular distal radius fracture
  • Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
  • Low energy trauma
  • Injury <72 hours when diagnosed
  • Patient independent of help for ADL

Exclusion Criteria:

  • Earlier dysfunction in any wrist
  • Other major injuries
  • Rheumatoid arthritis or other systemic joint disease
  • Dementia or severe psychiatric disease
  • Severe medical condition making general anesthesia a considerable risk

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: External fixation
Operation with external fixation and optional addition of k-wire
Procedure: External fixation
Operation with external fixation and optional addition of k-wire
Other Names:
  • External Fixation with Hoffman external fixator (Stryker)
Active Comparator: Volar plate
Operation with Synthes volar two column plate (TCP)
Procedure: Volar plate
Operation with a Synthes volar two column plate (TCP)
Other Names:
  • Synthes volar two column plate (TCP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.
Time Frame: 12 months
12 months
A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Sari Ponzer, Professor, Karolinska Institutet

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

August 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRF Extra

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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