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Completed

NCT Number: NCT00989222

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.

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Key information

Conditions

Radius Fractures Arm Injuries Forearm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, S-18288, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
  • Patient aged 20-70 years with no previous fracture of either wrist.

Exclusion criteria

  • Bilateral fractures,
  • Other current injury to the upper extremities,
  • Dementia, OR
  • Severe comminution or too small distal fragment to allow plating.

Treatment and study plan

closed reduction and external fixation

Procedure

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Other names: External fixation: Hoffman compact

Internal fixation with a volar locked plate

Procedure

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Other names: Volar locked plate brand: Königsee by Swemac

Primary outcomes

  1. PRWE (patient rated wrist evaluation) score

    Time frame: 3,6 and 12 months

Secondary outcomes

  1. Objective function (range of movement and grip strength)

    Time frame: 3,6 and 12 months

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Official study title

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 5, 2009
Registry last updated
Oct 5, 2009

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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