UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius

Abstract

BackgroundIn high-income countries, 6% of all women will have sustained a fracture of the wrist (distal radius) by the age of 80 years and 9% by the age of 90 years. Advances in orthopaedic surgery have improved the outcome for patients: many such fractures can be treated in a plaster cast alone, but others require surgical fixation to hold the bone in place while they heal. The existing evidence suggests that modern locking-plate fixation provides improved functional outcomes, but costs more than traditional wire fixation.MethodsIn this multicentre trial, we randomly assigned 461 adult patients having surgery for an acute dorsally displaced fracture of the distal radius to either percutaneous Kirschner-wire fixation or locking-plate fixation. The primary outcome measure was the Patient-Rated Wrist Evaluation©(PRWE) questionnaire at 12 months after the fracture. In this surgical trial, neither the patients nor the surgeons could be blind to the intervention. We also collected information on complications and combined costs and quality-adjusted life-years (QALYs) to assess cost-effectiveness.ResultsThe baseline characteristics of the two groups were well balanced and over 90% of patients completed follow-up. Both groups of patients recovered wrist function by 12 months. There was no clinically relevant difference in the PRWE questionnaire score at 3 months, 6 months or 12 months [difference at 12 months: –1.3; 95% confidence interval (CI) –4.5 to 1.8;p = 0.398]. There was no difference in the number of complications in each group and small differences in QALY gains (0.008; 95% CI –0.001 to 0.018); Kirschner-wire fixation represents a cost-saving intervention (–£727; 95% CI –£588 to –£865), particularly in younger patients.ConclusionsContrary to the existing literature, and against the increasing use of locking-plate fixation, this trial shows that there is no difference between Kirschner wires and volar locking plates for patients with dorsally displaced fractures of the distal radius. A Kirschner-wire fixation is less expensive and quicker to perform.Trial registrationCurrent Controlled Trials ISRCTN31379280.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 17. See the NIHR Journals Library website for further project information.

Is it time to revisit the AO classification of fractures of the distal radius?

“…Patients were recruited as part of a United Kingdom National Institute for Health Research clinical trial, between August 2010 and June 2012. 10 Adult patients were eligible to enter the study if they had sustained a dorsally displaced fracture of the distal radius, defined as within 3 cm of the radiocarpal joint, which the consulting surgeon considered suitable for fixation. Patients were excluded if they had an open fracture (Gustilo grade > 1), if the fracture could not be reduced closed, if there were contraindications to surgery or if the patient was unable to comply with the main procedures in the trial.…”

Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius

“…The only other inclusion criterion was that the treating surgeon believed that the patient would benefit from surgical fixation of the fracture. Further details of the protocol are reported elsewhere (Costa et al, 2011). The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) (MacDermid et al, 1998).…”

Verifying participant reported clinical outcomes: challenges and implications

“…Within a research context, self-reporting of clinical outcomes (for example fracture, re-operation, and hospitalisation) by participants is common (for example Costa et al 2015 [4], Ashby et al 2014 [5]).…”