Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT): a randomised controlled trial, economic evaluation and nested qualitative study of cast versus surgical fixation for the treatment of adult patients with a bi-cortical fracture of the scaphoid waist

Jospeh Dias, Stephen Brealey, Liz Cook, Caroline Fairhurst, Sebastian Hinde, Paul Leighton, Surabhi Choudary, Matthew Costa, Catherine Hewitt, Stephen Hodgson, Laura Jefferson, Kanagaratnam Jeyapalan, Ada Keding, Matthew Northgraves, Jared Palmer, Amar Rangan, Gerry Richardson, Nicholas Taub, Garry Tew, John ThompsonDavid Torgerson

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Abstract

Background: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased.

Objective: To compare clinical and cost-effectiveness of surgical fixation with cast treatment and early fixation of those that fail to unite for scaphoid waist fractures in adults.

Design: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and nested qualitative study.

Setting: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013 with final follow-up in September 2017.

Participants: Adults (aged ≥ 16 years), presenting within two weeks of injury with a clear bicortical fracture of the scaphoid waist on plain radiographs.

Interventions: Early surgical fixation using CE marked headless compression screws. Below elbow cast immobilisation for six to ten weeks, and urgent fixation of confirmed non-union.

Main outcome measures: The primary outcome and end-point was the Patient Rated Wrist Evaluation (PRWE) total score at 52 weeks, with a clinically relevant difference of six points. Secondary outcomes included PRWE pain and function subscales, Short Form 12-item questionnaire (SF-12), bone union, range of movement, grip strength, complications and return to work.

Results: The mean age of 439 participants was 33 years, 363 were male (83%) and 269 had an undisplaced fracture (61%). The primary analysis was on 408 participants providing valid PRWE outcome data for at least one post-randomisation time-point (surgery n=203 of 219; cast n=205 of 220). There was no clinically relevant difference in the total PRWE at 52 weeks: cast group mean 14.0 [95% confidence interval (CI) 11.3 to 16.6] and surgery group mean 11.9 (95% CI 9.2 to 14.5); adjusted mean difference of -2.1 in favour of surgery (95% CI -5.8 to 1.6, p=0.27). Non-union rate was low (surgery group n=1; cast group n=4). Eight participants in the surgery group had 11 re-operations, and one participant in the cast group required a re-operation for non-union. The base-case economic analysis at 52 weeks found the cost of surgery was £1,295 more per patient (95% CI £1,084 to £1,504) than cast treatment. The base-case analysis of a lifetime extrapolated model confirmed that the cast treatment pathway was the most cost-effective option. The nested qualitative study identified patients desire to have a “sense of recovering” which surgeons should address at the outset.

Limitation: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, 14 within six months from randomisation and three after six months. Three of four participants in the cast group, who had a non-union at 52 weeks, were not offered surgery.

Conclusions: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed.

Future work: Patients will be followed-up at five years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life.
Original languageEnglish
JournalHealth Technology Assessment
Publication statusAccepted/In press - 29 Mar 2019

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