Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035359
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : March 13, 2014
Information provided by (Responsible Party):
Sari Ponzer, Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dorsally Displaced Intraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial.
Study Start Date : August 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: external fixation
Operation with external fixation and optional addition of k-wire
Procedure: External fixation
Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)
Other Name: Stryker's Hoffman external fixation
Experimental: Volar plate
Operation with a Synthes volar two column plate (TCP)
Procedure: Volar plate
Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.
Other Name: Synthes Two Column Plate (TCP)

Primary Outcome Measures :
  1. 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 :
  1. A secondary outcome is the degree of malalignment on the x-ray of the injured wrist. [ Time Frame: 12 months ]
  2. A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035359

Stockholm South Hospital Department of Orthopeadic Surgery
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet

Responsible Party: Sari Ponzer, Professor, MD, Senior consultant orthopaedic surgeon, Karolinska Institutet Identifier: NCT01035359     History of Changes
Other Study ID Numbers: DRF intra
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Sari Ponzer, Karolinska Institutet:

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries