title: Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial.
abstract: BACKGROUND
  Distal 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
  This 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.
  
  
  CONCLUSIONS
  Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type.
  
  
  BACKGROUND
  ACTRN12612000969864.
authors.forename: Gregory B
authors.initials: GB
authors.lastname: Couzens
authors.affiliation: Brisbane Hand and Upper Limb Research Institute, 9/259 Wickham Tce, Brisbane, QLD 4001, Australia. research@upperlimb.com.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Peters
authors.forename: Kenneth
authors.initials: K
authors.lastname: Cutbush
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hope
authors.forename: Fraser
authors.initials: F
authors.lastname: Taylor
authors.forename: Christopher D
authors.initials: CD
authors.lastname: James
authors.forename: Carly R
authors.initials: CR
authors.lastname: Rankin
authors.forename: Mark
authors.initials: M
authors.lastname: Ross
mesh_terms: D001860:Bone Plates; D002985:Clinical Protocols; D003100:Colles' Fracture / Q000000981:diagnostic imaging / Q000534:rehabilitation / Q000601:surgery; D004867:Equipment Design; D005260:Female; D005593:Fracture Fixation, Internal / Q000295:instrumentation*; D017102:Fracture Healing; D018737:Hand Strength; D006801:Humans; D008297:Male; D010147:Pain Measurement; D018579:Patient Selection; D011788:Quality of Life; D011859:Radiography; D011885:Radius Fractures / Q000000981:diagnostic imaging / Q000534:rehabilitation / Q000601:surgery*; D016059:Range of Motion, Articular; D020127:Recovery of Function; D013193:Stainless Steel; D014025:Titanium; D015599:Trauma Severity Indices; D014954:Wrist Injuries / Q000601:surgery
chemical_list: D013193:Stainless Steel; D014025:Titanium