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.
A 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.



We 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.



Scaphoid 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.



The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.
AToMS - Academic Team of Musculoskeletal Surgery, Undercroft (nr Ward 28), University Hospitals of Leicester NHS Trust, Leicester General Hospital, Gwendolen Road, Leicester, LE5 4PW, UK. jd96@leicester.ac.uk.
Joseph
J
Dias
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Stephen
S
Brealey
Department of Radiology, University Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.
Surabhi
S
Choudhary
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Liz
L
Cook
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, The Kadoorie Centre, John Radcliffe Hospital, Oxford, OX3 9DU, UK.
Matthew
M
Costa
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Caroline
C
Fairhurst
York Trials Unit and NIHR RDS YH, Department of Health Sciences, Faculty of Science, University of York, ARRC Building, Heslington, York, YO10 5DD, UK.
Catherine
C
Hewitt
Bolton NHS Foundation Trust, Trust HQ, Royal Bolton Hospital, 1st Floor, Minerva Road, Farnworth, Bolton, BL4 0JR, UK.
Stephen
S
Hodgson
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Laura
L
Jefferson
Department of Diagnostic Radiology, University Hospitals of Leicester, The Glenfield Hospital, Groby Road, Leicester, LE3 9QP, UK.
Kanagaratnam
K
Jeyapalan
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Ada
A
Keding
School of Medicine, University of Nottingham, Nottingham Health Science Partners, C-Floor South Block, Queens Medical Centre, Nottingham, NG7 2UH, UK.
Paul
P
Leighton
South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.
Amar
A
Rangan
Centre for Health Economics, University of York, Heslington, York, YO10 5DD, UK.
Gerry
G
Richardson
Centre for Health Economics, University of York, Heslington, York, YO10 5DD, UK.
Claire
C
Rothery
Department of Health Sciences & NIHR Research Design Service for the East Midlands, University of Leicester, Centre for Medicine, University Road, Leicester, LE1 7RH, UK.
Nicholas
N
Taub
Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, University of Leicester, Centre for Medicine, University Road, Leicester, LE1 7RH, UK.
John
J
Thompson
York Trials Unit and NIHR RDS YH, Department of Health Sciences, Faculty of Science, University of York, ARRC Building, Heslington, York, YO10 5DD, UK.
David
D
Torgerson
D000328:Adult; D001863:Bone Screws; D002370:Casts, Surgical; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D050723:Fractures, Bone / Q000000981:diagnostic imaging / Q000601:surgery*; D017759:Fractures, Malunited / Q000150:complications / Q000517:prevention & control*; D006801:Humans; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D011859:Radiography; D016059:Range of Motion, Articular; D020127:Recovery of Function; D021361:Scaphoid Bone / Q000000981:diagnostic imaging / Q000293:injuries* / Q000601:surgery; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D006113:United Kingdom; D014954:Wrist Injuries / Q000000981:diagnostic imaging / Q000601:surgery*; D014955:Wrist Joint / Q000502:physiology; D055815:Young Adult
Plaster cast; Randomised controlled trial; Scaphoid fracture; Screw fixation; Union