Dias et al.

BMC Musculoskeletal Disorders (2016) 17:248

DOI 10.1186/s12891-016-1107-7

STUDY PROTOCOL Open Access

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
Joseph Dias1*, Stephen Brealey2, Surabhi Choudhary3, Liz Cook2, Matthew Costa4, Caroline Fairhurst2,
Catherine Hewitt5, Stephen Hodgson6, Laura Jefferson2, Kanagaratnam Jeyapalan7, Ada Keding2, Paul Leighton8,
Amar Rangan9, Gerry Richardson10, Claire Rothery10, Nicholas Taub11, John Thompson12 and David Torgerson5

Abstract
Background: 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.
Methods/Design: 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.
(Continued on next page)

* Correspondence: [email protected]
1
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
Full list of author information is available at the end of the article

© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 2 of 15

(Continued from previous page)

Discussion: 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.
Trial registration: The trial is registered with the International Standard Randomised Controlled Trial Register
(ISRCTN67901257). Date registration assigned was 13/02/2013.
Keywords: Scaphoid fracture, Screw fixation, Plaster cast, Union, Randomised controlled trial

Background an expected incidence of scaphoid waist fractures of

Scaphoid fracture is the most common carpal fracture 4140, 4169 and 4197 (population of 51.1, 51.4 and 51.8
and is an important public health problem as it predom- million respectively in England in 2007, 2008 and 2009
inantly affects young active individuals (mean age and based on a rate of 81 acute scaphoid fractures/mil-
29 years [1]) in their most productive working years. lion population per year) [17]. We had to estimate this
These fractures account for 2 to 7 % of all fractures [2]. as currently the diagnosis of cases that do not receive
However, 10 to 12 % do not unite when treated with surgical treatment, or those treated only in the out-
plaster cast, with a higher incidence of non-union (14 to patient setting, are not recorded in HES. The rate of sur-
50 %) in displaced fractures [3–5]. Non-union, if un- gical fixation [18] rose very slightly from 37 to 41 %
treated almost inevitably leads to arthritis, usually within from 2007/8 to 2008/9 but then increased sharply to
5 years of injury [6, 7]. This can potentially disable pa- 62 % in 2009/10. This trend of increasing intervention
tients at a relatively young age. rate for these fractures emphasises the urgent need for
Recent systematic reviews [8–12] have found insuffi- this study.
cient evidence from randomised controlled trials (RCTs) Little is published on patient experiences after a
to inform clinical decisions on the treatment of scaphoid scaphoid fracture and issues pertinent to recruiting par-
waist fractures. Eight small RCTs comparing surgery with ticipants into surgical RCTs [19, 20]. There is also poor
non-operative management [12] could not establish information on the economic aspects [21] of this injury
whether patients who had surgical fixation of undisplaced and its treatment.
or minimally displaced scaphoid fractures had better lon- These limitations, identified in the current evidence
ger term outcomes. Surgery in these RCTs was shown to base, justify this adequately powered study. It will con-
facilitate early return of function, but had a higher compli- tribute to the evidence base for sound clinical decisions
cation rate (between 9 and 22 %) compared with conser- for the treatment of this common fracture in predomin-
vative management although the complications were antly young adults.
usually minor [1, 13, 14]. The rate of union was similar be-
tween surgical and cast treatment with early fixation of Methods/Design
those fractures that failed to unite [1]. A further study Design
found similar outcomes at 10 years [15]. This is a pragmatic, multi-centre RCT, investigating
Despite insufficient evidence there is a rapidly increas- whether immediate surgical fixation of minimally dis-
ing trend [16] for immediate surgical fixation compared placed fractures of the scaphoid waist leads to better pa-
to cast immobilisation for 6 weeks and fixing only those tient reported outcomes when compared to initial non-
10 to 12 % that fail to unite [1]. This current trend to fix operative treatment with later surgical fixation of only
fractures may be attributed to potential short-term bene- those fractures that fail to unite. The study includes an
fits, but concerns remain about the lack of evidence on economic analysis and has a nested qualitative study to
long-term benefits and additional risks from surgery, explore patient experiences of their treatment. The ob-
such as malunion, infection, implant related problems jectives are listed in Table 1.
and avascular necrosis (AVN). The trial is registered as ISRCTN67901257 and can be
Hospital Episode Statistics (HES) for National Health found by searching at http://www.isrctn.com/ at the time
Service (NHS) hospitals in England recorded a near of registration we were not explicit that the pain and
doubling (1534, 1720 and 2582) of acute scaphoid frac- function sub-scales of the primary outcome would be in-
ture fixations for the years 2007/8, 2008/9 and 2009/10 cluded as secondary outcome measures, this had been
respectively. In each of these three years we calculated included in the grant application.
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 3 of 15

Table 1 SWIFFT trial objectives

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.

Setting Trial interventions

The Chief Investigator together with the British Society Cast treatment
for Surgery of the Hand (BSSH) obtained agreements to Control treatment is non-operative with immobilisation
participate from 17 hand units in NHS Hospital Trusts in a below elbow cast for 6 to 10 weeks, followed by mo-
in the United Kingdom across a range of urban and rural bilisation. Pragmatically we have not specified whether
areas. The pragmatic design of the trial and wide clin- the thumb should be included in the cast as this does
ician involvement ensures immediate applicability and not affect union rate [3], but we will record the type of
generalisability of the trial findings. Table 2 shows a list cast used. Early Computerised Tomogram (CT) will be
of all participating hospital sites that have been set up to obtained at the discretion of the treating surgeon if plain
recruit patients into the trial. radiographs at 6 to 12 weeks raise the suspicion of non-
union which we expect in 10 to 12 % of non-operatively
Study participants treated patients. If non-union is confirmed on radio-
Patients are eligible for this study if they graphs and/or CT scan, urgent surgical fixation will be
performed. The surgical procedure and post-operative
1. are skeletally mature and aged 16 years old or above care will be similar to the surgical arm of this trial. This
2. present at a participating site within two weeks of is the current standard non-operative pathway [1].
their injury
3. have a clear, unequivocal bicortical fracture of the Surgery
scaphoid waist confirmed on a series of plain Immediate surgical fixation avoids the need to immobil-
radiographs of the scaphoid which ise the wrist in a cast and may accelerate return of func-
a. does not involve the proximal pole (proximal fifth tion [22] but requires the individual to have surgery and
of the scaphoid) and be exposed to surgical risks.
b. is minimally displaced with less than or equal to Surgical treatment is by percutaneous or open surgical
2 mm step or gap on any view. fixation with standard CE marked headless compression
screws [14, 23, 24] which avoid the pressure effects of
Patients will be excluded from this study if the screw head on articular cartilage. The surgical tech-
niques are well described and are now standard [25–27].
1. their fracture has >2 mm displacement as these are We will not restrict the type of implant used but will
likely to be unstable record what screw was used. We will not specify the
2. they have a concurrent wrist fracture in the opposite surgical approach or the postoperative care as most sur-
limb geons currently use some splintage for the first few
3. they have a trans-scaphoid perilunate dislocation weeks after surgery. It will be agreed at each recruiting
4. they have multiple injuries in the same limb site which surgeons will fix the scaphoid fractures and
5. they lack mental capacity to comply with treatment that these surgeons should use techniques with which
or data collection they are familiar.
6. they are pregnant because radiation exposure would
be contraindicated Rehabilitation
7. they are not resident in the trauma catchment area All patients randomised into the two groups will receive
of a participating site to allow follow-up. standardised, written physiotherapy advice detailing the
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 4 of 15

Table 2 SWIFFT participating hospital study sites any other rehabilitation input beyond the written infor-
Study sites mation sheet (including a formal referral to physiother-
1. Basingstoke and North Hampshire Hospital apy) is at the discretion of the treating surgeon.
2. Royal United Hospital Bath NHS Trust
However, a record of any additional rehabilitation input
(type of input and number of additional appointments)
3. Birmingham – Queen Elizabeth Hospital
is to be recorded at the 52 week follow-up.
4. Bolton NHS Foundation Trust
5. Brighton and Sussex University Hospitals NHS Trust
Outcome measures
6. Bristol Royal Infirmary
Table 3 outlines the time points where various outcomes
7. Addenbrookes Hospital are assessed. These outcomes are described below.
8. University Hospital Wales, Cardiff
9. Royal Cornwall Hospital Primary outcome
10. Coventry The primary outcome and end-point for the trial is the
11. Gloucestershire Royal Hospital Patient Rated Wrist Evaluation (PRWE) total score at
12. King’s College Hospital NHS Foundation Trust 52 weeks from randomisation.
13. Leicester Royal Infirmary
14. Royal Liverpool University Hospital Patient rated wrist evaluation
15. Maidstone and Tunbridge Wells NHS Trust The PRWE is completed at baseline for the time before
and after injury, and at 6, 12, 26, 52 weeks and 5 years
16. Medway Maritime Hospital
after randomisation. The PRWE is a 15-item question-
17. Musgrove Park Hospital
naire that is completed by the patient. It is a brief, reli-
18. Newcastle upon Tyne Hospitals NHS Foundation Trust able and valid instrument for assessing wrist pain and
19. North Bristol NHS Trust disability [28, 29]. Scoring for all the questions is on a
20. Nottingham University Hospitals NHS Trust 10-point, ordered scale ranging from ‘no pain’ or ‘no dif-
21. John Radcliffe Hospital, Oxford ficultly’ (0) to ‘worst ever pain’ or ‘unable to do’ (10).
Two non-overlapping subscales are generated: pain and
22. Peterborough City Hospital
function and a total score can be computed on a scale of
23. Derriford Hospital, Plymouth
0 to 100 (0 = no disability) where pain and function do-
24. Poole Hospital mains are weighted equally.
25. Royal Preston Hospital PRWE has been chosen as the primary outcome as
26. Royal Berkshire Hospital patient reported functional outcomes are favoured for
27. Salford Royal Hospital NHS Foundation Trust decision making and it allows assessment of both wrist
pain and function.
28. University Southampton NHS Trust
29. The Royal London Hospital
Timing of primary outcome
30. The James Cook University Hospital, Teesside
Two small RCTs [1, 14] of patients with fractures of the
31. North Tyneside General Hospital
scaphoid have demonstrated that there is little change in
32. Chelsea and Westminster Hospital NHS Foundation Trust objective and subjective outcomes between 26 and
33. Alexandra Hospital, Redditch 52 weeks. For the 10 to 12 % of patients who are treated
34. Southport and Ormskirk Hospitals NHS Trust initially in cast but do not heal, surgery should be per-
formed between 6 and 12 weeks from randomisation.
exercises they need to perform for rehabilitation follow- Therefore, if assessed at 26 weeks this would leave only
ing their injury. All patients in both groups will be ad- 14 to 20 weeks for healing and recovery to take place.
vised to move their shoulder, elbow and finger joints To allow all patients the time to heal from surgery and
fully within the limits of their comfort. Those patients recover from complications we have chosen 52 weeks as
treated in a cast will perform range-of-movement exer- the primary end point.
cises at the wrist as soon as their plaster cast is removed
at the 6-week follow-up appointment if there are no Secondary outcomes
concerns regarding bone union. Those patients who Patient rated wrist evaluation
have the fracture fixed may begin wrist exercises as soon PRWE total scores at other time points (6, 12, 26 weeks
as comfort permits if they do not have a plaster cast or and 5 years) as well as the PRWE subscale scores of pain
as soon as the cast is removed. In this pragmatic trial, and function will be secondary outcomes.
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 5 of 15

Table 3 Timescale of enrolment, interventions and follow-ups for patients

a
Where possible the CT should be done before randomisation, if this is not feasible it must be scheduled before surgery and must be done within two weeks of a
patient’s injury
b
Patients allocated to surgery must receive this within two weeks from when the patient presents to A&E or other point of contact (e.g. walk-in centre,
cottage hospital)
c
Patients are initially put into plaster cast for 6 to 10 weeks. If non-union is confirmed on X-rays/CT at 6 or 12 weeks urgent surgical fixation will be performed
d
These X-rays/CT are those routinely collected whereas at the other time-points are compulsory
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 6 of 15

Short form 12-item questionnaire (SF-12) This reflects common and evidence-based practice in
The SF-12 is a 12 item generic patient-reported outcome assessing grip strength [50]. The Beighton Joint Laxity
measure of physical and mental health, the population Score (excluding the thumb count for the injured wrist)
norms of which have a mean of 50 and standard devi- will be recorded at baseline to measure hypermobility of
ation of 10; higher scores indicate better health [30]. The joints [51]. These assessments will be standardised
SF-12 is completed at 6, 12, 26 and 52 weeks and at across participating sites using an instruction manual.
5 years to measure the potential broader consequences
of a scaphoid fracture on both the participants’ physical Return to work and recreational activities
and mental health. This will be established through patient self-report on
the number of days off work and ability to perform usual
EuroQol (EQ-5D-3L) activities when at work and when performing unpaid
The EQ-5D is a validated, generic patient-reported out- recreational activities. This will be recorded at 6, 12, 26
come measure covering five health domains (mobility, and 52 week follow-up.
self-care, usual activities, pain/discomfort and anxiety/
depression). We will use the original EQ-5D which con-
tains three response options within each of the five do- Complications
mains [31, 32]. The use of this non-fracture-specific Expected and unexpected complications will be recorded
instrument will allow us to assess health-related quality at the 6, 12 and 52 week visit. The expected complica-
of life outcomes in the health economic analysis. The tions include:
EQ-5D has high validity and reliability in proximal hu-
merus fractures [33] and hip fractures [34]. The EQ-5D 1. Infection, defined as for the “Surgical Site Infection”
is completed at baseline, 6, 12, 26 and 52 weeks. audit [52].
2. Delayed wound healing, defined as any wound that
Bone union has not healed by two weeks.
The secondary outcome of bone union [35] is determined 3. Complex Regional Pain Syndrome (CRPS), defined
at 52 weeks (in line with the primary end point) using a as puffy painful swelling of the whole hand
CT scan and plain radiographs comprising posterior- restricting full tuck of the fingers at 2 weeks.
anterior, lateral, semi 45° prone, semi 45°supine views and 4. Nerve events (hypoaesthesia or numbness in the
an elongated scaphoid view e.g. Ziter type view [36]. territory of the palmar cutaneous branch of the
Union is defined as complete disappearance of the fracture median nerve, superficial division of the radial nerve
line [3] on radiographs and complete bridging on CT or the median nerve).
scans [37–39] from those taken at baseline. We will iden- 5. Vessel events (large (>2 cm) haematoma in the line
tify partial union based on the proportion of the fracture of the radial artery).
plane traversed by bridging trabeculae on true sagittal and 6. Screw related complications (protrusion of either
coronal formats of the scaphoid on CT. We are using CT end into the adjacent joint, fracture or bending of
to determine non-union as there is only poor to moderate the screw, a radiolucent halo around any part of the
inter-observer agreement (range of Kappa from 0.11 to screw > 1 mm, screw backing out or moving).
0.53) when determining the union of a scaphoid fracture 7. Degenerative change in the adjacent joints [53].
on plain radiographs [40]. We will assess scaphoid fracture 8. Avascular necrosis (AVN) of the proximal pole of
displacement on radiographs and on a CT scan [41] and the scaphoid.
determine malunion [42] on the 52 week CT scan (ratio of
Scaphoid Height to Length ≥ 0.6) in the true sagittal axis Five year clinic review
of the scaphoid to assess any humpback deformity [43]. The long-term consequences of cast immobilisation and
internal fixation have not been adequately determined in
Objective measures RCTs. Therefore, at five years after their original injury,
We are measuring the range of movement [44] of both all remaining trial participants will be asked to attend a
wrists using a goniometer and grip strength [45–48] of follow-up visit at a participating hospital for a clinical
both hands using a calibrated Jamar dynamometer at and radiographic follow-up. The clinical examination
baseline, 6, 12, 52 weeks and 5 years. will include inspection and evaluation of scar sensibility
The measurements will be done with the subject when applicable, palpation for tenderness, measurement
seated, arm by the side, elbow bent at 90° and the wrist of joint movement with a goniometer, as well as meas-
in neutral position for rotation [49]. The second setting urement of grip strength and pinch strength [15].
on the Jamar dynamometer will usually be used but pa- Participants will complete a questionnaire that asks
tients with large hands may need to use the third setting. about perceived hand problems (e.g. weakness of wrist,
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 7 of 15

reduced range of movement) as well as the primary out- non-operative management. We judge that a 6 point im-
come measure, the PRWE, and EQ-5D. provement in the PRWE in the surgery group (compared
to the controls) would be a minimal clinical important dif-
Participant timeline ference. We estimate the standard deviation of PRWE at
Figure 1 illustrates the process of enrolling partici- 52 weeks to be 20 points from the PRWE User manual
pants into the study, the interventions being com- [54]. This figure is reported for distal radius fracture rather
pared, and timing of assessments and hospital visits than scaphoid fracture at 6 months. The only published
for the participants in the trial. evidence for scaphoid fracture implies a standard devi-
ation in the range of 8 to 10 points [15]; however, this esti-
Sample size mate was at a median of ten years after the patient’s
For surgery to justify its increased costs and the exposure injury. To be conservative we have chosen the estimate of
to risk, it must result in greater or quicker improvement standard deviation to be 20, which gives a standard effect
in patients’ wrist symptoms and function compared with size of 0.3 for the 6 point PRWE difference.

Fig. 1 Flow of participants in the SWIFFT trial

Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 8 of 15

We will use a superiority design to observe an effect Recruitment

size of 0.3 at 80 % power using a 2-sided 5 % significance Strategies for achieving adequate participant enrolment
level requiring 350 participants in total. After allowing to reach target sample size include seeking advice from
for 20 % attrition we need to recruit and randomise 438 our patient focus group, sharing best practice with our
participants (219 surgery and 219 controls). The esti- Research Nurses, and bi-annual discussion with our
mate of attrition is likely to be realistic given that four Principal Investigators at the scientific meetings of the
RCTs (three studies were single centre and one study BSSH. Table 4 shows the project plan and milestones.
had two centres) included in a systematic review of the Hospital staff will be provided with training at the Site
treatment of scaphoid fractures found response rates for Initiation Visits and a Trial Site Manual to ensure adher-
completion of patient-reported functional outcomes be- ence to the delivery of the interventions in the trial. Dur-
tween 77 and 100 % [12]. ing the trial, training and reminders will be implemented
To minimise attrition we will exclude the rare patient using e-mail bulletins, face-to-face meetings with the
in this population who lacks mental capacity and there- PI’s at BSSH conferences and a training day with Re-
fore unlikely to comply with treatment or data collec- search Nurses. In addition the Trial Co-ordinators will
tion. Active and systematic follow-up of all randomised provide support and guidance to staff when required
participants will be conducted at 6, 12, 26 and 52 weeks (e.g. when new staff join or replace existing site staff )
when we will arrange for the questionnaire to be com- and will seek clinical guidance from the CI when
pleted when the participant attends the clinic. An add- necessary.
itional 5 year review is also planned. We will monitor To assess adherence with the trial protocol, sites will
the completion of questionnaires at clinics and share re- be asked at the 6 and 12 week hospital visits to complete
tention figures with each trial site blinded by centre. a ‘Treatment Confirmation Form’. This will be used to
At 52 weeks a £40 payment will be made to patients record the treatment that the patient received after ran-
who attend the clinic. Concurrently we will employ a domisation and reasons for any change in treatment. It
proven postal strategy for the return of questionnaires. also asks whether non-union is suspected for patients
This will include the use of reminder letters after 2 and randomised to conservative treatment. This will allow
4 weeks and the option for completion of an abridged the trial team to check with the hospital site that surgi-
questionnaire (a minimum of the primary outcome and cal fixation is being offered to these patients. Trial par-
EQ-5D) via telephone after 6 weeks. At 52 weeks only ticipants are also asked at their 12 week follow-up how
(the primary time-point for the study), in addition to the many of the home exercises they have performed and
6 week telephone call we will write to non-responding how useful they found the leaflet detailing exercises they
patients to ask them to complete the PRWE to help need to perform for rehabilitation.
maximise return of the primary outcome. We will still
call the patient to complete the remainder of the ques-
tionnaire over the telephone. At 26 weeks, when the pa- Table 4 Time schedule of the study project plan
tient does not need to attend for a hospital appointment, Time period (month) Activity
we will include an unconditional incentive payment of 1–3 Complete local R&D approval and set up for 4
£5 with the postal questionnaire. We will also circulate a sites
regular newsletter and update the trial website (http:// 4–6 Initiate early recruitment (internal pilot study at
www.swifft.co.uk/), to keep the participants informed of 4 sites and continue R&D approval for other sites)
study progress and engaged with the trial. A trial ‘tagline’ 7–36 Main recruitment for trial
will be placed on postal envelopes to patients to high- 37–48 Complete final 12 month follow-up
light the importance of patients’ involvement in the re- 49–54 Analysis and write up of main HTA monograph
search. At the five year follow-up, participants will
55–63 Preparation for 5 year clinic review
receive £80 to attend hospital for their clinic review
which should cover time off work, travel and parking 64–96 Conduct 5 year clinic review
costs. Finally, to minimise attrition bias, as there is ran- 64–69 Internal pilot follow-up for 5 year review
domised evidence in a recent systematic review that the 70–72 Three months to follow-up the last participant to
return of postal questionnaires can be improved when be followed-up for the internal pilot
patients are included in a prize draw [55], those pa- 73–75 If internal pilot is unsuccessful, to complete analysis
tients who return the questionnaire at 26 weeks could and write up the report
win an iPad worth £500. When patients attend their 97–105 Allow 9 months to complete clinics and prepare
analysis
hospital clinic appointment at 52 weeks and 5 years,
they will be entered into additional prize draws to win 106–108 Complete analysis and write HTA addendum
monograph
an iPad worth £500.
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 9 of 15

Randomisation consultant musculoskeletal radiologists and a consultant

The Research Nurse will identify potentially eligible orthopaedic surgeon.
patients presenting in Accident and Emergency (A&E) As the non-union rate for displaced fractures is 14 %
Departments, or referred from various sources (e.g. walk- compared with 10 % for transverse undisplaced fractures
in centre, cottage hospital), and at fracture clinics. The [3, 5, 56], randomisation will be stratified by the pres-
orthopaedic surgeon will confirm eligibility and invite the ence or not of displacement of a scaphoid fracture as
patient to consider joining the study. The Research Nurse seen on radiographs [5, 56] Within strata, a sequence of
or clinician will then provide an information sheet and an- confidential random block sizes will be used to generate
swer any questions. The patient will be asked whether the block allocation sequence. To avoid predictability of
they agree to consent at that time or are offered up to the randomisation we will not stratify by site. The radio-
48 h to discuss the study and their participation with graphic views to assess displacement should include the
family or friends before deciding. semi 45° prone, semi 45°supine and an elongated scaph-
When patients have given consent their baseline forms oid view e.g. Ziter [36] type view (Fig. 2). Displacement
will be completed and randomisation done. The Re- is defined as a step greater than 1 mm and less than or
search Nurse or recruiting clinician will contact York equal to 2 mm or a gap greater than 1 mm and less than
Trials Unit, either by telephone or via the internet, to or equal to 2 mm as seen on the radiographic views.
access the secure randomisation service. This will ensure This magnitude of displacement will avoid compromis-
treatment concealment and unbiased allocation. Once ing surgeon equipoise for non-operative treatment as
eligibility is confirmed, patients will be randomised (via displacement >2 mm suggests significant instability and
a secure, computer generated allocation sequence) to re- therefore the need for surgical intervention.
ceive immediate surgical fixation or immobilisation of
the wrist in a cast. Data management
Patients and their clinician will be informed of the al- Case Report Forms will be used to record all the infor-
locations. As the trial is pragmatic and compares surgery mation required from the protocol. Essential Trial docu-
with initial cast treatment, blinding of participants and mentation which individually and collectively permits
clinicians to treatment allocation is not possible. When evaluation of the conduct of a clinical trial and the qual-
possible, the surgeon will take no part in the postopera- ity of the data produced will be kept within the Trial
tive subjective assessment of patients. The statistical Master File and Investigator Site Files. The Sponsor will
analysis will also be performed blind as far as possible. ensure that this documentation is retained for a mini-
We will mitigate against bias by ensuring that all radio- mum of five years after the conclusion of the trial and a
graphs and CT scans are assessed by two independent minimum of 20 years in electronic format in accordance

Fig. 2 Radiographic views of a scaphoid fracture. Four radiographic views shown here, and a fifth elongated scaphoid view, establish the
presence of a “clear” and ”bicortical” fracture of the waist of the scaphoid. Such patients are eligible for the SWIFFT trial. These radiographs also
help determine whether the fracture is displaced for blocked randomisation after obtaining consent
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 10 of 15

with guidelines on Good Research Practice. Paper data injury PRWE scores will be presented in total and for
will then be disposed of securely and electronic data will each treatment group and compared descriptively to
be anonymous of identifiable information. PRWE scores post-injury at baseline and all other
All study-related information will be stored securely in follow-up time points.
the co-ordinating centre at the University of York or at Our primary analysis will compare total PRWE scores
an alternative secure off-site facility. All electronic re- between treatment groups at 52 weeks using a covari-
cords will be stored on a password-protected server. All ance pattern mixed model incorporating all post-
participant data will be identified by a coded ID (identifi- randomisation time points, where effects of interest and
cation) number to maintain participant confidentiality. baseline covariates are specified as fixed effects, and the
All participant information will be stored in locked cabi- correlation of observations within patients over time
nets in areas with restricted access. Data on trial partici- (random effect) is modelled by a covariance structure.
pants’ X-rays and CT scans will be stored securely at The outcome modelled will be PRWE at 6, 12, 26 and
The University Hospitals of Leicester NHS Trust. Partic- 52 weeks, predicted by treatment group, time, treatment
ipants’ data may be reviewed by authorised persons on group-by-time interaction and adjusting for age, fracture
the research team or other authorised people to verify displacement (undisplaced vs. minimally displaced)
that the study is being carried out correctly all of whom and hand dominance. Estimates of the difference be-
will have a duty of confidentiality. Trial participants will tween treatment groups in total PRWE scores will be
give permission for this authorised review of their data derived at all time points with 95 % confidence inter-
at the time of consent. All names and other identifying vals and p-values. The primary end point will be the
information will be removed before the data is analysed treatment effect estimate at 52 weeks. This model will
and the results presented to the medical community at naturally include all patients who provide data for the
conferences and in scientific journals. baseline covariates, and valid PRWE data for at least
The Data Monitoring and Ethics Committee (DMEC) one post-randomisation follow-up time point.
will be the only body to have access to the unblinded The impact of missing PRWE outcome data will be
comparative data from the trial. The role of its members minimised to some extent by using the mixed model,
is to monitor these data and make any recommendations which allows the inclusion of intermittent responders in
to the Trial Steering Committee (TSC) on whether there the primary analysis. PRWE scores for complete and
are any ethical or safety reasons why the trial should not intermittent responders will be compared descriptively.
continue. The TSC will provide overall supervision for The impact of missing data will additionally be assessed
the trial on behalf of the Sponsor and Funder. using multiple imputation by chained equations. Missing
outcome and covariate data will be predicted by age,
Statistical analysis plan fracture displacement, hand dominance, available PRWE
A detailed analysis plan will be agreed with the Data data at other follow-up time points, and any baseline co-
Monitoring and Ethics Committee at an early stage of variates found to be predictive of missing 12 month out-
the study, before all of the data has been collected. Any come data.
subsequent amendments will be clearly stated and justi- All secondary outcomes will be summarised descrip-
fied. All analyses will be conducted on an intention to tively. The following outcomes will be analysed using
treat basis, including all available randomised partici- the same methods as the primary analysis adjusting for
pants in the groups to which they were allocated. Ana- the same covariates: pain and disability subscales of the
lyses will be conducted using 2-sided significance tests PRWE, physical health and mental health component
at the 5 % significance level (unless otherwise stated). summaries of the SF-12 and range and grip strength.
The statistician conducting the analyses will remain Where available, baseline values of the dependent vari-
blind to treatment group until all data summaries and able will also be included as a covariate in the models.
results are finalised. For some variables the type of data The presence of any complication assessed by clinical
reveals treatment allocation (e.g. complication data), examination up to 52 weeks will be analysed by logistic
hence relevant analyses will be conducted by a second regression (sufficient numbers permitting). Complications
statistician. will be defined as medical, surgical or plaster cast related.
The flow of participants through each stage of the trial Union will be assessed as a percentage (0–100 %) and
will be presented in a CONSORT flow diagram [57]. categorised as: total non-union [0 %]; slight union [>0–
PRWE scores will be summarised descriptively (number, 20]; partial union [>20–70]; mostly united [>70–<100];
mean, standard deviation, median, interquartile range, and complete union [100 %]. Summary statistics for union
minimum and maximum) at each time point by treat- will be presented at each time point by trial arm. Union
ment group and overall. PRWE at baseline will be will be dichotomised into a ‘Probably need surgery’
collected for the time before and after injury. Mean pre- group [0–20 %] and a ‘Probably do not need surgery’
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 11 of 15

group [>20–100 %] and analysed using a logistic regres- Detailed information will be collected on the costs of
sion adjusting for treatment group. surgical fixation, including time in theatre, drugs and
Two subgroup analyses will be undertaken: one ex- hospital bed usage, and the costs associated with plaster
ploring patient preferences (surgery, plaster cast, no cast treatment. The impact of the two treatments on
preference) and the second exploring the type of fracture subsequent morbidity costs will be assessed. The use of
displacement (undisplaced, displaced), for any differen- hospital readmissions, outpatient attendances, general
tial effect of the trial treatments in these subgroups. practice, community and personal health services will be
Each baseline factor (preference or displacement) and its collected during the various follow-up points through
interaction with the randomised treatment group will be administered questionnaires. The primary perspective of
added to the primary analysis model. Our expectation is the analysis will be that of the NHS and Personal Social
for patients who preferred surgery to benefit more from Services, consistent with that used by the National Insti-
surgery over plaster cast treatment and conversely for tute for Health and Care Excellence [58]. Private expen-
patients who preferred plaster cast to benefit more from ditures related to treatment will also be recorded and
plaster cast than surgery. For patients with a displaced these costs will be included in a secondary analysis.
fracture we expect them to benefit more following sur- Health outcomes will be expressed in terms of the
gery than patients whose fracture is undisplaced. Since quality-adjusted life year (QALY) using the EQ-5D data
the trial is not powered for these subgroup analyses, any collected at baseline, 6, 12, 26, and 52 weeks follow-up.
inferences will be made with caution. The EQ-5D scores will be converted into QALYs using
The number of adverse events experienced by each area under the curve analysis [59].
participant and the total number of events overall will Cost and QALY data will be synthesised to generate
be summarised for each treatment group. an incremental cost effectiveness ratio (ICER) [60]. Mul-
tivariable regression analyses will be used to assess het-
Interim analysis erogeneity in costs, QALYs and cost effectiveness.
There are no planned interim analyses for the trial or The 5-year follow-up review will facilitate an add-
stopping guidelines. There will, however, be an internal itional analysis that examines the relationship between
pilot study from which the data will contribute to the outcomes reported at 1 year and 5 years. If considered
final analyses. The primary reason for this pilot study appropriate, structural equation modelling [61] will be
will be to check the assumptions about recruitment and used to determine the factors that predict outcomes at
feasibility of the trial. The DMEC and TSC will review 5 years and to assess the predictive performance of out-
the pilot data and recommend whether any changes are comes at 1-year. This may also be used to assess the
required to the trial team and whether the trial should cost-effectiveness of following patients up at 5 years
continue or not. Furthermore, as we did not have data post-surgery in general practice.
on the standard deviation of our primary outcome at
one year, we will estimate this for the patients recruited Qualitative study of patient experience
into the internal pilot study. This will inform the poten- The qualitative data collected in the nested study will be
tial need to increase the planned sample size as recom- used to generate a model (or models) which reflect pa-
mended by the independent DMEC. tient experiences of wrist fracture and treatment, and
which identify difficulties and advantages of the different
Cost-effectiveness analysis treatment options. Such models are likely to focus upon
The economic evaluation will assess the relative cost- personal and lifestyle attributes as well as physical recov-
effectiveness of surgical fixation compared with plaster ery, and to incorporate a range of non-clinical factors
cast treatment. Costs and health outcomes associated which are not routinely considered in clinical interac-
with the interventions will be collected during the 1-year tions. Insight into participation in a clinical trial will also
trial period. However, the trial data is unlikely to provide be generated.
all the evidence to inform the decision on whether surgi- Sampling to the nested qualitative study will be pur-
cal treatment represents a cost-effective option to the posive to include men and women from different trial
NHS. Therefore, these costs and outcomes will be ex- sites, of different ages, occupations and leisure/sporting
trapolated and modelled over a longer time horizon than activities, and those with scaphoid fractures on their
captured by the trial (e.g. lifetime of the patient) if this is dominant and non-dominant sides. The sample will be
appropriate given the results of the trial. The additional drawn primarily from those individuals recruited to the
data from the 5-year follow-up review on the long-term trial (n to be determined by concerns for data saturation,
consequences of cast immobilisation and internal fix- see below). In addition, up to ten individuals who de-
ation, which are not adequately captured in RCTs, will cline participation in the trial will be interviewed to ex-
be used to update the model results once available. plore their experience of fracture and their reasons for
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 12 of 15

not taking part in the RCT. All participants will be inter- tuberosity, and chondrolysis. There are also adverse
viewed within 6 weeks of their treatment and those in events specific to the plaster cast which are expected
the trial will be interviewed again following collection of and do not need reporting to REC: soft cast/broken cast
clinical and other data at the primary end-point that leads to movement of wrist, pressure sores, CRPS,
(52 weeks). nerve compression, or pain due to tight cast. Movement
All interviews will be semi-structured with open ques- in a cast is an untoward event as it can mean the frac-
tions used to guide a discussion of a patient’s experience ture is not properly immobilised which can result in fail-
of treatment, their opinions about treatment benefits ure of the fracture to unite.
and drawbacks, their reflections upon wrist fracture and Serious adverse events that are confirmed to be related
recovery, and their attitudes towards participating in to the research and are unexpected will be reported to
clinical research. All interviews will be digitally recorded REC. All AEs will be routinely reported to the TMG,
and transcribed in full. DMEC, and Sponsor. The DMEC will be responsible for
Following the conventions of the constant comparative reviewing related and unexpected serious adverse
method, [62, 63] data analysis will be carried out along- events.
side data collection, with interviews transcribed and ana- All AEs that are unresolved at initial reporting will be
lysed in batches before further data are collected. In this reviewed by the Chief Investigator a month later to en-
way, the process is iterative with models and theories de- sure that adequate action has been taken and progress
veloped from ‘within’ the interviews rather than from made to manage the adverse event. Additional reviews
existing theory or clinical practice and tested or refined at one month intervals will be conducted when neces-
in the collection of more data. sary until the Chief Investigator decides that no further
These models will be further tested and constantly re- reporting is required.
fined as new data are considered. Data collection, and The Chief Investigator will also be informed, by the re-
analysis, ceases when no new themes or ideas are viewers of the X-rays/CT scans collected for the study,
present in the interview data, and when the model of pa- of any abnormalities identified. The Chief Investigator
tient experience is stable and no longer growing or will judge whether the abnormality is clinically import-
evolving. This point is known as data saturation [64], ant and could impact on patient safety (e.g. a protruding
previous research suggests that this is often reached with screw). The need to notify the Principal Investigator of
as few as 10–13 interviews [65] – we are conducting the site, and whether to record this as an AE, will also
around 40 interviews to include at least 15 from each be considered. No actions or treatments will be dis-
treatment arm to enable data saturation. Data from cussed between the Investigators.
those individuals not in the main trial will be considered
alongside this data, and considered separately to inform Quality control
practical concerns of trial recruitment. The University Hospitals of Leicester NHS Trust will be
Within this study we would expect to generate up to 4 the Sponsor for this project. This study will be fully
interrelated models of patient experience: i) reporting compliant with the Research Governance Framework
patients’ experiences of wrist fracture, its impact upon and Medical Research Council Good Clinical Practice
their lifestyle, everyday functioning and their recovery; Guidance. If a patient wishes to complain formally, they
ii) reporting the benefits and difficulties associated with will be advised to do this through the usual NHS Com-
surgical fixation; iii) reporting the benefits and difficul- plaints Procedure. If a patient is harmed and this is due
ties associated with plaster cast treatment and, iv) to someone’s negligence then they may have grounds for
reporting experiences and attitudes towards involvement legal action or compensation against the Sponsor (in re-
in surgical, clinical research. spect of harm arising out of participation in the trial) or
the NHS (in respect of any harm which has resulted
Adverse event management from the treatment received).
Adverse events (AEs) related to the scaphoid fracture in- Review of core trial processes will be undertaken by
jury and its treatment during the 12 months after ran- the Trial Management Group (TMG) on a quarterly
domisation will be recorded by site Investigators and the basis which includes representation from the Sponsor.
categorisation of causality and expectedness confirmed These meetings focus on aspects of patient recruitment
by the Chief Investigator. AEs that may be expected with (e.g. enrolment, consent, eligibility); allocation to study
this injury to the wrist or a consequence of the trial groups; adherence of the trial interventions to the proto-
treatments that do not need to be reported to the Re- col; monitoring of adverse events and reasons for patient
search Ethics Committee (REC) include infection, de- withdrawal; and retention of trial participants. When ne-
layed wound healing, CRPS, nerve or vessel events, cessary the review will be undertaken at a recruiting site
screw related complications, fracture of scaphoid level and information feedback to the Principal
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 13 of 15

Investigator and Research Nurses at each site. Independ- Trial Manager and Senior member of York Trials Unit
ent review of the trial processes is undertaken every six will then agree on this. Order of authorship will be de-
months by the DMEC and TSC. These committees assist termined by individuals’ completion of the Author Order
the TMG with their audit of trial processes and advise Form which weights their contribution to elements of
on strategies to preserve the integrity of the trial. preparing the manuscript. Any individual who feels the
order of the authorship does not reflect their input will
Protocol modifications notify this to the Chief Investigator, Trial Manager and
Important protocol modifications are those that are Senior member of York Trials Unit. There are no plans
likely to affect to a significant degree: the safety, physical to use professional medical writers to assist with the
or mental integrity of the subjects of the study; the sci- preparation of trial reports or publications.
entific value of the study; or the conduct or management
of the study. These substantial amendments will be sub-
Discussion
mitted to REC for approval having been agreed with: the
Scaphoid fractures are an important public health problem
Funding Body, Sponsor, TSC, DMEC, TMG and the
as they predominantly affect young active individuals in
Research Governance Committee for the Department of
the more productive working years of their lives. Non-
Health Sciences, University of York. Minor modifica-
union, if untreated, can lead to arthritis which can disable
tions to the protocol will be agreed with the TMG and
patients at a very young age. There is a rapidly increasing
Sponsor before submission for approval to REC. All
trend for immediate surgical fixation of these fractures but
amendments will be implemented in the NHS organisa-
there is insufficient evidence from existing RCTs to sup-
tions in agreement with the guidance of the Health
port this. The SWIFFT Trial is a rigorously designed and
Research Authority. Trial participants will be written to,
adequately powered study which aims to contribute to the
if necessary, to explain any changes. All amendments
evidence-base for informing clinical decisions for the
whether substantial or not will be listed in the published
treatment of this common fracture in adults.
Final Report to the Funding Body.

Dissemination policy Abbreviations

AVN, avascular necrosis; BSSH, British Society for Surgery of the Hand;
This protocol is being made publically available. It is CONSORT, Consolidated Standards of Reporting Trials; CRPS, complex
planned for the full Trial Report up to the 52 week regional pain syndrome; CT, computerised tomogram; DMEC, Data
follow-up to be submitted to the Funding Body and for Monitoring and Ethics Committee; EQ-5D, EuroQol 5 Dimensions; HES,
Hospital Episode Statistics; ICER, incremental cost effectiveness ratio; ISRCTN,
publication in a peer-reviewed journal.. The full trial re- International Standard Randomised Controlled Trial Number; NHS, National
port will be open access and made available as a per- Health Service; PRWE, Patient Rated Wrist Evaluation; QALY, quality-adjusted
manent archive in the NIHR Journals Library. At the life year; RCT, Randomised Controlled Trial; REC, Research Ethics Committee;
SF-12, Short Form 12-Item Questionnaire; SWIFFT, Scaphoid Waist Internal
time of publishing the protocol there was no plan to Fixation for Fractures Trial; TMG, Trial Management Group; TSC, Trial Steering
make the anonymised participant level dataset and stat- Committee
istical code for generating the results publicly available.
After publication, however, of the main trial findings, an Acknowledgements
external request that is made for this data and code will SWIFFT Trial Sponsor: University Hospitals of Leicester NHS Trust.
SWIFFT Trial Patient Representative: Mr Ashley Langton.
be agreed by the TMG and confirmed with the Sponsor Trial Steering committee: Prof Wendy Baird (Independent Chair - Director NIHR RDS
and Funding Body. for Yorkshire and Humber); Mr Peter Burge (Independent Member - Consultant
The criteria for authorship and contributorship will be Hand Surgeon, Oxford), Dr Jonathan Cook (Independent Member - Statistician,
University of Oxford), Mr Nick Welch (Independent Member – Member of BOA
taken from the International Committee of Medical Patient Liaison Group) and Mr Richard Palmer (Independent Member – Member of
Journal Editors [66]. Those who did not design the study BOA Patient Liaison Group).
or contribute to drafting the work but were involved in Data Monitoring Ethics Committee: Mr Graeme MacLennan (Independent
Chair – Senior Statistician, University of Aberdeen), Mr Adam Watts
the trial conduct (e.g. staff at recruiting sites) will be ac- (Independent Member – Consultant Hand Surgeon, Wrightington) and
knowledged as collaborators. When a journal permits we Mr Timothy Hems (Independent Member – Consultant Hand Surgeon, Glasgow).
will list all authors rather than use a group name. There Miss Roseanne Billany (Clinical Research Assistant – University Hospitals of
Leicester NHS Trust).
will be a designated writing group for each publication Mr Chris Bunce (Research Assistant - University Hospitals of Leicester NHS
and one or more lead writers who convene the group. Trust).
Any member of the trial team can propose a publication Mrs Paula Cowan (Research Secretary – University of York).
Mrs Elaine James (Trial Administrator - University Hospitals of Leicester NHS
to the Chief Investigator, Trial Manager and Senior Trust).
member of York Trials Unit. All members of the trial Mr Matthew Northgraves (Trial Co-ordinator - University of York).
team will be informed of the proposal who will suggest Dr Sarwat Shah (Trial Co-ordinator – University of York).
Dr Garry Tew (Trial Co-ordinator - University of York).
whether they consider themselves to be a potential Mrs Nicola Woofenden (Research Secretary - University Hospitals of Leicester
author, contributor or neither. The Chief Investigator, NHS Trust).
Dias et al. BMC Musculoskeletal Disorders (2016) 17:248 Page 14 of 15

Funding 0JR, UK. 7Department of Diagnostic Radiology, University Hospitals of Leicester,

The research costs of the study will be funded by the National Institute for The Glenfield Hospital, Groby Road, Leicester LE3 9QP, UK. 8School of Medicine,
Health Research Health Technology Assessment Programme (project number University of Nottingham, Nottingham Health Science Partners, C-Floor South
11/36/37). The views and opinions expressed therein are those of the Block, Queens Medical Centre, Nottingham NG7 2UH, UK. 9South Tees Hospitals
authors and do not necessarily reflect those of the HTA programme, NIHR, NHS Foundation Trust, The James Cook University Hospital, Marton Road,
NHS or the Department of Health. The funder had no part in the design of Middlesbrough TS4 3BW, UK. 10Centre for Health Economics, University of York,
the study and will not have any role in its implementation, analysis, data Heslington, York YO10 5DD, UK. 11Department of Health Sciences & NIHR
interpretation and presentation of the results. The individual National Health Research Design Service for the East Midlands, University of Leicester, Centre for
Service providers at the participating hospital sites cover any excess Medicine, University Road, Leicester LE1 7RH, UK. 12Department of Health
treatment costs of the surgical intervention. Sciences, College of Medicine, Biological Sciences and Psychology, University of
Leicester, Centre for Medicine, University Road, Leicester LE1 7RH, UK.
Availability of data and material
Not applicable for this manuscript. Received: 26 April 2016 Accepted: 28 May 2016

Authors’ contributions
JD is the Chief Investigator who led the design of the study and led the References
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