Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

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

Dorsally Displaced Intraarticular 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

Detailed Description

This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits

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

      • Stockholm, Sweden, 11883
        • 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 intraarticular 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 major 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: external fixation
Operation with external fixation and optional addition of k-wire
Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)
Other Names:
  • Stryker's Hoffman external fixation
EXPERIMENTAL: Volar plate
Operation with a Synthes volar two column plate (TCP)
Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.
Other Names:
  • Synthes 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 is the degree of malalignment on the x-ray of the injured wrist.
Time Frame: 12 months
12 months
A secondary outcome of this study is the EQ5D, which is 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.

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

Other Study ID Numbers

  • DRF intra

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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