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Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial

Dias, Joseph; Brealey, Stephen; Fairhurst, Caroline; Amirfeyz, Rouin; Bhowal, Bhaskar; Blewitt, Neil; Brewster, Mark; Brown, Daniel; Choudhary, Surabhi; Coapes, Christopher; Cook, Liz; Costa, Matthew; Davis, Timothy; DisMascio, Livio; Giddins, Grey; Hedley, Helen; Hewitt, Catherine; Hinde, Sebastian; Hobby, Jonathan; Hodgson, Stephen; Jefferson, Laura; Jeyapalan, Kanagaratnam; Johnston, Phillip; Jones, Jonathon; Keding, Ada; Leighton, Paul; Logan, Andrew; Mason, Will; McAndrew, Andrew; McNab, Ian; Muir, Lindsay; Nicholl, James; Northgraves, Matthew; Palmer, Jared; Poulter, Rob; Rahimtoola, Zulfi; Rangan, Amar; Richards, Simon; Richardson, Gerry; Stuart, Paul; Taub, Nicholas; Tavakkolizadeh, Adel; Tew, Garry; Thompson, John; Torgerson, David; Warwick, David

Authors

Joseph Dias

Stephen Brealey

Caroline Fairhurst

Rouin Amirfeyz

Bhaskar Bhowal

Neil Blewitt

Mark Brewster

Daniel Brown

Surabhi Choudhary

Christopher Coapes

Liz Cook

Matthew Costa

Timothy Davis

Livio DisMascio

Grey Giddins

Helen Hedley

Catherine Hewitt

Sebastian Hinde

Jonathan Hobby

Stephen Hodgson

Laura Jefferson

Kanagaratnam Jeyapalan

Phillip Johnston

Jonathon Jones

Ada Keding

Paul Leighton

Andrew Logan

Will Mason

Andrew McAndrew

Ian McNab

Lindsay Muir

James Nicholl

Jared Palmer

Rob Poulter

Zulfi Rahimtoola

Amar Rangan

Simon Richards

Gerry Richardson

Paul Stuart

Nicholas Taub

Adel Tavakkolizadeh

Garry Tew

John Thompson

David Torgerson

David Warwick



Abstract

Background
Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less.

Methods
This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1–2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing.

Findings
Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2–14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference −2·1 [95% CI −5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group).

Interpretation
Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite.

Citation

Dias, J., Brealey, S., Fairhurst, C., Amirfeyz, R., Bhowal, B., Blewitt, N., Brewster, M., Brown, D., Choudhary, S., Coapes, C., Cook, L., Costa, M., Davis, T., DisMascio, L., Giddins, G., Hedley, H., Hewitt, C., Hinde, S., Hobby, J., Hodgson, S., …Warwick, D. (2020). Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial. Lancet, 396(10248), 390-401. https://doi.org/10.1016/S0140-6736%2820%2930931-4

Journal Article Type Article
Acceptance Date Apr 16, 2020
Online Publication Date Aug 6, 2020
Publication Date Aug 8, 2020
Deposit Date May 15, 2020
Publicly Available Date Feb 7, 2021
Journal The Lancet
Print ISSN 0140-6736
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 396
Issue 10248
Pages 390-401
DOI https://doi.org/10.1016/S0140-6736%2820%2930931-4
Keywords Scaphoid fracture; Screw fixation; Plaster cast; Union; Randomised controlled trial
Public URL https://hull-repository.worktribe.com/output/3508796
Publisher URL https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30931-4/fulltext#articleInformation

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