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Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

This study has been completed.
Information provided by (Responsible Party):
Sari Ponzer, Karolinska Institutet Identifier:
First received: December 16, 2009
Last updated: March 12, 2014
Last verified: March 2014
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.

Condition Intervention
Dorsally Displaced Intraarticular Distal Radius Fractures
Age 50 - 74 for Females or 60-74 for Males
Low Energy Trauma
Procedure: External fixation
Procedure: Volar plate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 70
Study Start Date: August 2009
Study Completion Date: February 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Synthes volar two column plate (TCP)

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

Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01034943

Stockholm South Hospital Department of Orthopeadic Surgery
Stockholm, Sweden, 118 83
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Sari Ponzer, Professor Karolinska Institutet
  More Information

Responsible Party: Sari Ponzer, Professor, MD, Consultant orthopeadic surgeon, Karolinska Institutet Identifier: NCT01034943     History of Changes
Other Study ID Numbers: DRF Extra
Study First Received: December 16, 2009
Last Updated: March 12, 2014

Keywords provided by Karolinska Institutet:

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries processed this record on April 21, 2017