Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures

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.

Conditions

• Distal Radius Fractures

Interventions

PROCEDURE

Open Reduction and Internal Fixation

Fixation with volar locked plate

PROCEDURE

Non-Spanning External Fixation

Radio-radial external fixation

PROCEDURE

Closed Reduction with Percutaneous Fixation

Percutaneous intrafocal pinning (Kapandji technique)

Sponsors & Collaborators

• Orthopaedic Trauma Association

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Greg K Berry, MD FRCSC · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2016-12-31

Completion

2019-04-03

Countries

• Canada

Study Locations