Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial

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

Surgical Treatment of Unstable Distal Radius Fractures With a Volar Variable-Angle Locking Plate: Clinical and Radiological Outcomes

“…The bicortical purchase is another critical point in the management of complex fracture patterns and it can be achieved with flexible plate positioning in variable angle plates. The various fracture lines (proximal/distal and medial/lateral) are accommodated due to the flexibility offered by the variable angle system ( 25 ).…”

Titanium versus Stainless-Steel Plating in the Surgical Treatment of Distal Radius Fractures: A Randomized Trial

“…Despite documentation of hardware-related complications (specifically tendon injury) and despite the plethora of different types of plating systems and different materials used for fractures of the distal radius, the literature on low-profile titanium plates and implants for the treatment of these intra-articular fractures remains limited. 14,15 Van Nortwick et al discuss the difficulty in titanium plate removal due to titanium integration into the bone and mechanical binding between the titanium screw and plate. 10 Other studies evaluated complications of volar plating including transient nerve injuries, loss of reduction, and tendon irritation.…”

A study of grip strength among 20–49-year-old British adults and comparison to existing norms

“…21 It is therefore not surprising that the Jamar dynamometer continues to be used to report hand function [22][23][24] and grip strength outcomes of hand rehabilitation and surgery. [25][26][27][28] Grip strength can be compared to the contra lateral hand and reported as a percentage. 8,26,27 The effect of hand dominance on grip strength compared to the nondominant hand has been reported with some variation, less than 10% greater 29 and up to 12% greater.…”

“…21 It is therefore not surprising that the Jamar dynamometer continues to be used to report hand function 22–24 and grip strength outcomes of hand rehabilitation and surgery. 25–28…”