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Completed

NCT Number: NCT00908895

Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.

The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Département d'orthopédie, CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J1Z4, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Distal radius fracture Frykman I or II
  • Unstable fracture according to Lafontaine's criteria
  • Fracture line more than 1cm form the joint line
  • Closed fracture
  • Age > 18 years
  • Surgery performed between 72 hours from the trauma
  • Monotrauma
  • Patient signed the informed consent

Exclusion criteria

  • Distal radius fracture Frykman III-VI (intra-articular fracture)
  • Open fracture
  • Polytraumatism
  • Stable or non-displaced fracture

Treatment and study plan

Radio-radial fixator

Procedure

Using the Distal Radius Fixator from Synthes. A single splint for 5 days.

Percutaneous pinning

Procedure

Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.

Primary outcomes

  1. The Grip Strength

    Time frame: 6 months

    Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.

Secondary outcomes

  1. Range of Movement of Wrist

    Time frame: 6 months

    Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.

    Motion is described as a percentage of the opposite side.

Sponsors and collaborators

Lead sponsor

Hopital de l'Enfant-Jesus

Other

Registry information

Official study title

Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
May 27, 2009
Registry last updated
Mar 1, 2011

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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