Fractures of the distal radius: does operative treatment with a volar locking plate improve outcome?: a randomised controlled trial

Background and aims The advent of volar locking plates designed specifically for fractures of the distal radius has resulted in a major shift away from percutaneous fixation of these injuries. However, comparative studies have not always demonstrated better outcomes than those achieved with less invasive and potentially less expensive established techniques. The present study was a randomized controlled trial comparing the outcome of displaced distal radius fractures when treated with a volar locking plate or closed reduction and percutaneous wire fixation, with supplemental bridging external fixation when required. The primary research objective was to ascertain whether the use of volar locking plates improves functional outcome in the short and medium term. The secondary objective was to determine, through economic evaluation, whether the use of volar locking plates for distal radius fractures is of financial benefit to the health service. Methods A single-centre randomized controlled trial of pragmatic design, conducted in a tertiary care institution, with accompanying economic evaluation. 130 patients with displaced distal radius fractures were randomised to either volar locking plate (n=66) or conventional percutaneous fixation methods (n=64). Outcome assessments were conducted at 6 weeks, 12 weeks and 1 year. The primary outcome measure was the PEM score at one year. Secondary outcomes included the QuickDASH, PRWE, EQ-5D and SF-12 scores, range of motion, grip strength, radiographic and cost parameters. A cost-effectiveness analysis was performed from the perspective of the NHS, and in line with NICE guidance on the methods of technology appraisal. “Bottom up” micro-costing methods were used to calculate costs for each treatment pathway, prospectively collecting information on consumables, inpatient and outpatient resource use, complications and additional procedures up to a year post surgery. Main findings Patients in the volar locking plate group had significantly better PEM, QuickDASH, PRWE scores and range of motion at 6 weeks, with no differences at 12 weeks and 1 year. Grip strength was better for the plate group at all time points. The volar locking plate was better at restoring the radiographic parameters of palmar tilt and radial height. Despite the early functional advantage, patients did not return to work sooner. Quality of life scores were marginally, but not significantly, better for the plate group at early follow-up. Both groups returned to baseline at one year. NHS costs for the plate group were significantly higher. For an additional £713, VLP fixation offered 0.018 additional QALYs in the year post surgery. The incremental cost effectiveness ratio (ICER) for VLP fixation at NHS list price was £40,068. Conclusion The current study showed that use of a volar locking plate resulted in better early post-operative function. However, there was no significant difference at, or after 12 weeks. The volar locking plate achieved better radiographic reduction and measured grip strength, but this did not translate to a difference in function at 12 weeks and 1 year. The earlier recovery of function may be of advantage to some patients. However, in spite of their increasing use and popularity, volar locking plates were cost-ineffective according to NICE threshold criteria