CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 203 enrolled
Drug / intervention
Open Reduction and Internal Fixation +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00524719
NCT00524719N/ACompleted

A Prospective Randomised Trial Comparing Open Reduction and Internal Fixation, Non-Spanning External Fixation, and Closed Reduction With Percutaneous Fixation in Displaced Distal Radius Fractures With Joint Congruity

In Brief

A clinical study evaluating Open Reduction and Internal Fixation, Non-Spanning External Fixation, and 1 other intervention for Distal Radius Fractures. Completed, enrolled 203 participants across 1 site.

Detailed Summary

Distal radius fractures are the most common fracture to occur in the adult population, and those which are displaced but maintain joint congruity are the most common subtype. Locking-plate technology represents a true advance in the fixation of these fractures, especially in view of the ever increasing incidence of these injuries in an ageing and osteoporotic population throughout Europe and North America. These plates permit rigid fixation, even in osteopenic bone, while avoiding any tethering of soft tissues, as seen with external fixation and percutaneous pinning. For these reasons, this mode of fracture fixation has rapidly gained popularity. Unfortunately, there is presently little evidence to support their use over the more traditional methods of fixation (percutaneous pinning, external fixation). In addition, the technique for their application is more invasive and their cost is considerably greater than these latter two techniques. As such, it is pertinent to evaluate, in a scientifically sound fashion, the outcome of fixation with the three types of implant included in this study. The results of this clinical trial will allow the orthopaedic community to confidently recommend the fixation method which provides the optimal functional, clinical, and radiographic outcome for a patient suffering a displaced distal radius with preserved joint congruity. Null hypothesis: There is no difference in the functional, clinical, and radiographic outcomes of the three treatment methods. Hypothesis: Given the locking nature of modern screw-plate constructs, which produce excellent fixation even in osteopenic bone and permit early range of motion exercises; and given that plate fixation, in contrast to external fixation and percutaneous pinning, does not tether muscle, tendon, or capsule; plate fixation with a volar fixed-angle device should permit earlier and more aggressive rehabilitation and more rapid and complete regain of hand and wrist function when compared to stabilization with external fixation or percutaneous pinning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2007
Enrollment StartJan 1, 2007
Primary CompletionDec 1, 2016
Study CompletionApr 3, 2019
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 18.8 years ago

Interventions

Open Reduction and Internal Fixationprocedure

Fixation with volar locked plate

Non-Spanning External Fixationprocedure

Radio-radial external fixation

Closed Reduction with Percutaneous Fixationprocedure

Percutaneous intrafocal pinning (Kapandji technique)