Abstract
BackgroundDistal radius fractures are among the most common fractures seen in the hospital emergency department. Of these, over 40% are considered unstable and require some form of fixation. In recent years with the advent of low profile plating, open reduction and internal fixation (ORIF) using volar plates has become the surgical treatment of choice in many hospitals. However, it is currently unknown which plating system has the lowest complication rate and/or superior clinical and radiological outcomes following surgery. Few studies have compared different types of plates, which may have various features, different plate and screw designs or may be manufactured from different materials (for example, stainless steel or titanium). This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures: one made from stainless steel (Trimed™ Volar Plate, Trimed™, California, USA) and the other made from titanium (Medartis® Aptus Volar Plate, Medartis®, Basel, Switzerland). The primary aim of this study is to determine if there is a difference on the Patient Reported Wrist Evaluation six months following ORIF using a volar plate for adult patients with a distal radius fracture.Methods/DesignThis study will implement a randomized prospective clinical trial study design evaluating the outcomes of two different types of volar plates: one plate manufactured from stainless steel (Trimed™ Volar Plate) and one plate manufactured from titanium (Medartis® Aptus Volar Plate). The surgery will be performed at a major trauma hospital in Brisbane, Australia. Outcome measures including function, adverse events, range of movement, strength, disability, radiological findings and health-related quality of life will be collected at 6 weeks, 3, 6, 12 and 24 months following surgery. A parallel economic analysis will also be performed. This randomized clinical trial is due to deliver results in December 2016.DiscussionResults from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type.Trial registrationACTRN12612000969864
Highlights
Distal radius fractures are among the most common fractures seen in the hospital emergency department
Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type
Closed reduction and casting remain viable options for some non-displaced simple fractures of the distal radius, the role of open reduction and internal fixation (ORIF) continues to grow due to its ability to more reliably restore wrist anatomy, minimize immobilization and establish acceptable clinical outcomes [4]
Summary
Newer features of volar plates, such as locking and variable angle mechanisms, have been thought to further reduce complication rates and improve effectiveness in patients of all ages [6] This remains controversial as a number of complications including loss of fixation, tendon irritation or rupture, median nerve complications and distal radial ulnar joint dysfunction, have been reported in the literature [10,11]. A retrospective study of 115 patients with comminuted intra-articular distal radius fractures was performed by Richards et al who compared radiographic and clinical outcomes of patients treated with external fixation to those treated with volar plate internal fixation [10] They reported fewer complications, better range of movement, pain and functional scores in the ORIF group. The research question for this study is: Do patients who have their distal radius fractures internally fixated with a titanium plate have the same outcomes as patients who have their distal radius fractures internally fixated with a stainless steel plate?
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
