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

Distal radius fractures are among the most common fractures seen in the hospital emergency department. 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 systems have better clinical and radiological outcomes following surgery, and also the lowest complication rates. Few studies have compared different types of plates, which may have different plate and screw designs, features 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) and the other made from titanium (Medartis Volar Plate). This study will use a two group (intervention) blinded (blinded outcome assessor, blinded data analysis, concealed randomisation, blinded participant) randomised trial in an adult population. A suite of outcome measures recommended for this patient group will be used. These measures include an assessment of range of movement, strength, function (quickDASH and Patient Rated Wrist Evaluation), pain(VAS) , complications (medical chart and self-report), quality of life (EQ5D), radiological outcome (XRay) and patient satisfaction (VAS). These outcomes will be administered by a blinded assessor at seven time points: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.