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Surgery compared with cast immobilization for adults with a bi-cortical fracture of the scaphoid waist (SWIFFT): a multicentre, pragmatic, open-label, parallel-group, two-arm randomised clinical trial

journal contribution
posted on 20.04.2020, 13:30 by Joseph Dias, Stephen Brealey, Caroline Fairhurst, Rouin Amirfeyz, Bhaskar Bhowal, Neil Blewitt, Mark Brewster, et al.

Background

Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased, in spite of insufficient evidence of improved outcomes over non-surgical management. We compared the clinical effectiveness of surgical fixation with cast immobilization and early fixation of those that fail to unite, for ≤2 mm displaced scaphoid waist fractures in adults.

Methods

This pragmatic, multicentre, open-label, parallel-group, two-arm randomised clinical trial included adults who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear, bicortical fracture of the scaphoid waist on radiographs. Participants were randomly assigned to early surgical fixation or below-elbow cast immobilization followed by immediate fixation of confirmed non-union. The primary outcome was the Patient Rated Wrist Evaluation (PRWE) total score at 52 weeks post-randomisation. Registration ISRCTN67901257.

Findings

Of 439 randomised patients (mean age 33 years, 363 [83%] men), 408 (93%) were included in the primary analyses. There was no difference in PRWE score at 52 weeks (adjusted mean difference -2·1 points, 95% CI -5·8 to 1·6, p=0·27). There were no differences at 52 weeks for the PRWE pain or function subscales. More participants in the surgery group experienced a surgery-related potentially serious complication than in the cast group (n=31, 14% vs n=3, 1%), but fewer had cast-related complications (n=5, 2% vs n=40, 18%). The number experiencing a medical complication (n=4, 2% vs n=5, 2%) was similar in the two groups.”

Interpretation

Adult patients with ≤2 mm displaced scaphoid waist fracture should have initial cast immobilization and suspected non-unions confirmed and immediately fixed. This will help avoid risks of surgery and mostly limit its use to fixing non-union.

Funding

This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 11/36/37).


Funding

National Institute for Health Research Health Technology Assessment Programme (project number 11/36/37)

History

Citation

The Lancet (2020) In Press

Version

AM (Accepted Manuscript)

Published in

The Lancet

Publisher

Elsevier

issn

0140-6736

Acceptance date

16/04/2020

Copyright date

2020

Publisher version

TBA

Language

en