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Completed

NCT Number: NCT01034943

Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

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.

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Key information

Conditions

Dorsally Displaced Intraarticular Distal Radius Fractures Age 50 - 74 for Females or 60-74 for Males Fractures, Bone Low Energy Trauma Wounds and Injuries

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm South Hospital Department of Orthopeadic Surgery

Stockholm, Stockholm County, 118 83, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External Fixation

Procedure

Operation with external fixation and optional addition of k-wire

Other names: External Fixation with Hoffman external fixator (Stryker)

Volar plate

Procedure

Operation with a Synthes volar two column plate (TCP)

Other names: Synthes volar two column plate (TCP)

Primary outcomes

  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 outcomes

  1. A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.

    Time frame: 12 months

  2. A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Dec 18, 2009
Registry last updated
Mar 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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