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Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

This study has been completed.
Sponsor:
Information provided by:
Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT00908895
First received: May 26, 2009
Last updated: February 25, 2011
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Radius Fractures
 Procedure: Radio-radial fixator
Procedure: Percutaneous pinning
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Flu Fractures
U.S. FDA Resources

Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • The Grip Strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.


Secondary Outcome Measures:
  • Range of Movement of Wrist [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 120
Study Start Date: April 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908895

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

No publications provided

Responsible Party: Pelet Stéphane, MD, PhD, Hopital de l'Enfant-Jésus
ClinicalTrials.gov Identifier: NCT00908895     History of Changes
Other Study ID Numbers: PEJ-206
Study First Received: May 26, 2009
Results First Received: November 12, 2009
Last Updated: February 25, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 23, 2013