Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 26, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedResults Posted
Study results publicly available
June 7, 2010
CompletedMarch 1, 2011
November 1, 2009
4.1 years
May 26, 2009
November 12, 2009
February 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Grip Strength
Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
6 months
Secondary Outcomes (1)
Range of Movement of Wrist
6 months
Study Arms (2)
Radio-radial fixator
EXPERIMENTALPatients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
Percutaneous pinning
ACTIVE COMPARATORTwo K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Interventions
Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Distal radius fracture Frykman III-VI (intra-articular fracture)
- Open fracture
- Polytraumatism
- Stable or non-displaced fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Département d'orthopédie, CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J1Z4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Very long time between the end of the study and the manuscript preparation due to temporarily lack of statistician and the need for some national associations that the study is not published before presentation.
Results Point of Contact
- Title
- Dr Stéphane Pelet, MD, PhD
- Organization
- Département d'orthopédie, CHA-Pavillon Enfant-Jésus Québec
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 26, 2009
First Posted
May 27, 2009
Study Start
April 1, 2003
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
March 1, 2011
Results First Posted
June 7, 2010
Record last verified: 2009-11