Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial

Abstract

Objective To assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires. Design Multicentre randomised clinical superiority trial, Setting 36 hospitals in the UK National Health Service (NHS). Participants 500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation). Interventions Manipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice. Main outcome measures The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks. Results The mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference −0.34 (95% confidence interval −4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). Conclusions Among patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients’ wrist function at 12 months compared with a cast. Trial registration ISRCTN registry ISRCTN11980540 .

Cost-utility analysis of surgical fixation with Kirschner wire versus casting after fracture of the distal radius

“…The DRAFFT2 trial demonstrated that surgical fixation with K-wire did not improve patients’ wrist function at one year compared with casting following manipulation of a fracture of the distal radius. 6 However, one in eight patients treated with a moulded cast required later surgery during the first six weeks after their injury for loss of fracture position. To further inform decision-making in the treatment of patients with a distal radius fracture that can be reduced with a closed manipulation, this within-trial economic evaluation of the DRAFFT2 trial indicates that manipulation and K-wire fixation is slightly more costly and does not result in a significant increase in QALYs in comparison to moulded cast.…”

“…The corollary of this is that, when both procedures are being performed in the operating theatre, the absolute difference in cost is small, whereas the risk of patients requiring further surgery for loss of fracture reduction in the first six weeks is higher in the cast group (n = 33; 13%) compared with the K-wire group (n = 1; 0.4%). 6 Arguably, although a moulded cast is likely to be cost-effective overall in the 12 months following a manipulation of a fracture of the distal radius, the inconvenience and distress caused to the one in eight patients who required further surgery in the cast group may justify the small increase in cost associated with K-wire fixation.…”

“…The statistical and health economics protocol (SHEAP), 5 as well as the clinical results of the DRAFFT2 trial, 6 have been published elsewhere. In brief, DRAFFT2 is a multicentre clinical trial that was conducted at 36 NHS hospitals in the UK.…”

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“…The need for operative intervention (as opposed to casting and conservative management) in displaced distal radial fractures remains controversial 7. This multicentre, randomised, non-blinded clinical trial was conducted at 36 NHS Hospitals in the UK 8. The study sought to determine whether wrist function and quality of life were superior with image intensifier-guided manipulation and moulded cast by an orthopaedic specialist, or operative surgical fixation with K-wires plus cast.…”

Trauma

“…The Distal Radius Acute Fracture Fixation Trial (DRAFFT) is now a number of years old, and demonstrated that in those patients where a closed reduction can be achieved, the results of percutaneous Kirschner (K)-wires and open reduction and internal fixation with volar plates are equivalent. In the next of these large randomized controlled trials (RCTs), the team of investigators from Oxford (UK) asked the question, “Are even the K-wires required or would a plaster do?” 5 They performed a multicentre RCT in 500 adult patients with a displaced distal radius fractures requiring closed reduction comparing treatment with a moulded cast versus fixation with K-wires. Patients were recruited and then randomized to one treatment or another after manipulation of their cast.…”