Table 1 SWIFFT trial objectives

1

Our primary objective is to determine the effectiveness of surgical fixation versus non-operative plaster cast treatment (with fixation of those that fail to unite, estimated as 10 % to 12 % of the total) of scaphoid waist fractures in adults. Outcome will be assessed using the PRWE (a patient self-reported assessment of wrist pain and function) at 52 weeks which will be the primary end point. The PRWE will also be completed at 6, 12, 26 weeks and 5 years. The power of the study permits identification of a clinically meaningful difference of 6 points in the PRWE.

2

To assess secondary outcomes of radiological union of the fracture at 52 weeks using radiographs and CT scans; recovery of wrist range and strength; return to work and recreational activities and; complications.

3

To conduct an economic analysis to investigate the cost-effectiveness of surgical fixation versus initial immobilisation in a plaster cast.

4

To qualitatively explore patient experiences of the fracture and its treatment; and investigate attitudes towards, and experiences of, participating in a surgical, clinical research trial.

5

To undertake a 5 year clinical review of all trial participants to determine the long-term consequences of cast immobilisation and internal fixation.