Title: Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) Cast treatment versus surgical fixation of fractures of the Scaphoid waist in adults: –a Multi-centre Randomised Controlled Trial
Funder: Department of Health and Social Care

Abstract: Design: A multi-centre randomised trial of surgical fixation vs initial cast immobilisation of acute scaphoid fractures followed by fixation of the 10-12% that fail to unite, including an economic evaluation and a nested qualitative study to explore patients’ experience of the fracture and its treatment. Setting: 17 NHS hand surgery units have agreed to participate, ensuring wide surgeon involvement. The pragmatic design will make findings generalisable. Health technologies being assessed: Surgical treatment is open or percutaneous surgical fixation with headless compression screws, which are standard and avoid the effects of the screw head. These are unlikely to change in the next 5 years. Control treatment: immobilisation in a below elbow plaster cast for 6-10 weeks, followed by surgical fixation of the 10-12% that fail to unite reflecting current clinical practice. Target population: All skeletally mature patients aged 16 years old or above and presenting with a bicortical fracture of the scaphoid waist within 2 weeks of injury. We will include minimally displaced fractures with less than or equal to 2mm step or gap on radiographs as greater displacement would challenge surgeon equipoise. We will exclude fractures with displacement >2mm, fractures in the proximal pole (proximal 20%), patients with a trans-scaphoid perilunate dislocation, other injuries in the same limb or previous injury or disease in the same wrist, patients not resident in the trauma centre catchment area and patients who lack mental capacity to understand the trial or instructions for treatment. Measurement of outcomes and costs: The primary patient reported outcome is the Patient Rated Wrist Evaluation at 52 weeks, the primary time-point. The secondary outcome will include bone union on a CT scan at 52 weeks, SF-12, time to return to work and leisure, complications e.g. malunion, nerve injury, arthritis, osteonecrosis, implant problems and infection. Prospective data on NHS and indirect (employment) costs will be collected with EQ-5D to provide health utility data. For the qualitative study, by interview in the first 6 weeks and repeated at 52 weeks, randomly selected participants will be asked open ended questions about previous experience of fractures and their treatment, how they feel about being in a trial of different treatments and the advantages and drawbacks of their treatment. Data analysis will use the constant comparative method based on grounded theory. We will also recruit patients who did not consent to the main study to note their views. Sample size: We judge a 6 point improvement in the PRWE in the surgery group (compared to the controls) should be a minimally clinical important difference. We cautiously estimate the standard deviation to be 20, which gives an effect size of 0.3 and at 80% power using a 2-sided 5% significance level we need 350 participants. Allowing for 20% attrition we need to recruit and randomise 438 participants (219 surgery and 219 controls). Sampling to the nested qualitative study will be purposive intending to include men and women from different trial sites, of different ages, occupations and leisure/ sporting activities, and those with scaphoid fractures on their dominant and non-dominant sides. We are unlikely to need more than 40 participants to reach theoretical saturation. Project timetables: We envisage a 4.5 year main study: the first 6 months for training and completion of research governance arrangements at trial centres. The recruitment period will be for 30 (24+6 for slower recruitment) months and will include an internal pilot study to test recruitment assumptions. Patients will be followed up at 6, 12, 26 and 52 weeks. A further 6 months will allow complete data collection, analyses and write up of the main study. We have extended the study to include a 5 year review. The recruitment rate, analysis plan and 5 year review are discussed under “Additional Information”.

Lay abstract: Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people, and results from a fall on the hand or sudden forced twist of the wrist. The broken bone needs to be held still to allow nature to mend it. One in 10 scaphoid fractures when held in a plaster cast fails to heal properly (nonunion). This can cause more pain, reduce hand strength and make the use of the hand for day to day tasks at home and at work difficult. Arthritis in the wrist usually develops within 5 years if the bone does not heal. As the fracture occurs mostly in young men such arthritis in the wrist will affect the remainder of their lives and their capacity to earn. At present the usual treatment is to rest the wrist in a plaster cast for 6 to 10 weeks and allow the broken scaphoid bone to heal. About 9 out of 10 scaphoid fractures are treated successfully in a plaster cast. The 1 in 10 that do not heal are then operated on and held still with a screw. This is the standard treatment. However, in the last few years, another way of holding all of these fractures still while they heal has been to operate early on the wrist and to fix the broken bone with a special screw. The screw does not have a screw head and so does not protrude into joints. Any operation involves taking risk, such as that of getting infection and damaging the nerves or blood supply, but surgery may restore hand function earlier and avoid the need to have the wrist held in a plaster cast for 6-10 weeks. Both treatments are followed by careful return to full use of the hand. Surgery costs £5 million more each year than plaster cast treatment to look after the 5000 people who break this bone each year in the UK. We do not know which form of treatment is better. We also do not know what treatment people with this fracture would prefer. In order to find out which treatment for fracture of the middle of the scaphoid is better we propose to compare early surgery with the standard treatment in a plaster cast followed by early fixation of only the 1 in ten that do not unite. Patients who agree to be included in this trial will be allocated randomly to either have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast. We will assess outcome by asking patients to complete a questionnaire which measures wrist pain and function. We will also assess nonunion, poor union, return to work and leisure activities and any complications during the following year. In order to see whether one treatment is better than the other in the long term we will ask our patients to come back to be assessed 5 years later. We will see if their hand function had remained satisfactory, check whether arthritis was setting in and whether there were any changes around the screw. We will seek approval by the National Research Ethics Service, participation will be voluntary and signed informed consent will be obtained. At present surgeons recommend treatment and we know very little about what treatment patients themselves may prefer. We therefore propose to find out more about what patients experienced and would prefer. Some patients will be asked about their experiences of the fracture and its treatment and we will also ask for their views on taking part in such a study. We also do not know which treatment gives us more value for the money we spend. We propose to look at the costs of treatment, including the cost to our patient from the time lost from work and the cost of attending the hospital clinic. By doing this and looking at the benefits patients got from each of these two treatments we can assess the value for the money spent for each of these treatments. We propose to spend 4½ years doing the main study to answer whether one treatment is better than the other, what patients’ experiences and preferences are and to study the value for money for each treatment. We also propose that we take this opportunity and assess our patients at five years which will take a further 4½ years to complete and will not cost much more. We are a multidisciplinary team experienced in this kind of multi-centre trial: some of us are orthopaedic surgeons who are experts in fractures of the arm and hand; three are statisticians and three are health economists; there are trials specialists and research scientists. We need salary for the trial specialists, surgeon experts and a full-time trial manager who will be responsible for getting research governance approval, training and setting up participating sites, collecting data and writing the final report. Costs are also required for the CT scans before treatment, at 52 weeks and at 5 years solely used for this research to assess the extent of (a) healing of the fracture, (b) change in the shape of the bone and (c) any arthritis.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS