Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sari Ponzer, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01034943
First received: December 16, 2009
Last updated: March 12, 2014
Last verified: March 2014

December 16, 2009
March 12, 2014
August 2009
February 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01034943 on ClinicalTrials.gov Archive Site
  • A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dorsally Displaced Intraarticular Distal Radius Fractures
  • Age 50 - 74 for Females or 60-74 for Males
  • Low Energy Trauma
  • Procedure: External fixation
    Operation with external fixation and optional addition of k-wire
    Other Name: External Fixation with Hoffman external fixator (Stryker)
  • Procedure: Volar plate
    Operation with a Synthes volar two column plate (TCP)
    Other Name: Synthes volar two column plate (TCP)
  • Active Comparator: External fixation
    Operation with external fixation and optional addition of k-wire
    Intervention: Procedure: External fixation
  • Active Comparator: Volar plate
    Operation with Synthes volar two column plate (TCP)
    Intervention: Procedure: Volar plate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
February 2014
February 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01034943
DRF Extra
No
Sari Ponzer, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Sari Ponzer, Professor Karolinska Institutet
Karolinska Institutet
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP