Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults

Abstract

BackgroundA scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset.Methods/DesignWe will conduct a randomised controlled trial (RCT) of 438 adult patients with a “clear” and “bicortical” scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment.DiscussionScaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults.Trial registrationThe trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN67901257). Date registration assigned was 13/02/2013.

Interventions to improve retention in a surgical, clinical trial: A pragmatic, stakeholder‐driven approach

“…We have, however, also been interviewing patients who took part in the SWIFFT trial and individuals who did not. We expect these interview data will help to generate further insights into the experiences and attitudes of patients toward surgical, clinical research which may include how to enhance retention of trial participants …”

“…Here, we consider a stakeholder‐consultative process to inform retention strategies in the Scaphoid Waist internal Fracture Fixation Trial (SWIFFT) (http://www.nets.nihr.ac.uk/projects/hta/113637). This is a multicenter trial comparing surgical fixation versus plaster cast treatment for fracture of the scaphoid bone in adults . It is a trial with multiple data collection points that include both completion of standard research instruments via post and return visits to hospital clinic for additional clinical assessment and imaging.…”

“…This is a multicenter trial comparing surgical fixation versus plaster cast treatment for fracture of the scaphoid bone in adults. 35 It is a trial with multiple data collection points that include both completion of standard research instruments via post and return visits to hospital clinic for additional clinical assessment and imaging. The study primary endpoint is one year, with an additional five-year clinic review to establish long-term consequence of fracture and treatment.…”

Surgical treatment of non- and minimally-displaced acute scaphoid fractures favours over-conservative treatment but only in the short term: an updated meta-analysis

“…Recently Dias et al 26 have raised the required funding to initiate such a extensive trial. In 2013 they have started the SWIFFT trial randomizing 438 patients with non-displaced and minimally-displaced fractures (defined as <2 mm) to surgical fixation and conservative treatment.…”

Single versus double screw fixation for the treatment of scaphoid waist fractures: Finite element analysis and preliminary clinical results in scaphoid nonunion

“…[2] Currently, centrally placed single headless compression screw fixation is accepted as a standard technique for the treatment of scaphoid fractures. [3] Despite progression in the surgical techniques and development of better implants, nonunion in scaphoid fractures continues to be a challenging problem in hand surgery. In a previous meta-analysis, the nonunion rate in acute scaphoid fractures has been reported as high as 19%.…”