Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

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: NCT00908895
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : June 7, 2010
Last Update Posted : March 1, 2011
Information provided by:
Hopital de l'Enfant-Jesus

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Radius Fractures Procedure: Radio-radial fixator Procedure: Percutaneous pinning Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
Study Start Date : April 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Radio-radial fixator
Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
Procedure: Radio-radial fixator
Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
Active Comparator: Percutaneous pinning
Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Procedure: Percutaneous pinning
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 Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00908895

Canada, Quebec
Département d'orthopédie, CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada, G1J1Z4
Sponsors and Collaborators
Hopital de l'Enfant-Jesus

Responsible Party: Pelet Stéphane, MD, PhD, Hopital de l'Enfant-Jésus Identifier: NCT00908895     History of Changes
Other Study ID Numbers: PEJ-206
First Posted: May 27, 2009    Key Record Dates
Results First Posted: June 7, 2010
Last Update Posted: March 1, 2011
Last Verified: November 2009

Keywords provided by Hopital de l'Enfant-Jesus:
Radius fractures
Radio-radial fixator
Percutaneous pinning
Grip strength

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