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| [ Print-friendly version ] |
| Scaphoid Waist Internal Fixation for Fractures Trial: A trial evaluating cast versus surgical fixation for fractures of the scaphoid waist in adults |
| ISRCTN | ISRCTN67901257 |
| DOI | 10.1186/ISRCTN67901257 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Scaphoid Waist Internal Fixation for Fractures Trial: A trial evaluating cast versus surgical fixation for fractures of the scaphoid waist in adults |
| Scientific title | A multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of cast treatment versus surgical fixation for fractures of the scaphoid waist in adults |
| Acronym | SWIFFT |
| Serial number at source | HTA: 11/36/37 |
| Study hypothesis |
To assess the effectiveness and cost-effectiveness of surgical fixation versus plaster cast immobilisation for fractures of the scaphoid waist in adults.
More details can be found at http://www.hta.ac.uk/2960 |
| Lay summary |
Background and study aims
This study seeks to answer the question of whether adults with a fracture of the scaphoid waist should receive plaster cast treatment or surgical fixation? 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 usual standard treatment is to rest the wrist in a plaster cast for 6 to 10 weeks and allow the broken scaphoid bone to heal. 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. We do not know which treatment is better without the evidence from a sufficiently large and detailed study. Who can participate? Men and women, aged 16 or over, who have fractures of the scaphoid waist and present to the hospital fracture clinic within 3 weeks of their injury, provided no exclusion criteria apply. What does the study involve? Eligible participants who consent to take part will be assessed at baseline using questionnaires, grip and strength measurements for their hand and wrist function and X-rays and CT scans. Patients will then be allocated into one of two groups: the surgical group or plaster cast group. This is done through a computerised process called ‘randomisation’, which means participants are allocated to groups purely by chance, in a similar way to using the toss of a coin. Patients in the surgery group will receive an operation, carried out by an orthopaedic surgeon experienced in treating wrist fractures. The surgeon will then advise about the best care of the wrist after surgery, including the use of hand and wrist exercises. Patients in the plaster cast treatment group will have the plaster cast applied, which will usually remain in place for 6 to 10 weeks, depending on how well the bone is healing when it is examined. Once the cast is removed, the surgeon will advise about exercises for the wrist. If, upon examination at 6 or 12 weeks, the surgeon does not think that the bone is healing sufficiently in a cast, then further X-rays and/or a CT scan may be routinely requested to help them decide about the need for an operation to fix the bone in place. This can happen to around 1 in 10 patients and is normal practice for when the bone does not heal when treated in a plaster cast. To monitor their progress we will ask patients to attend follow-up appointments at the hospital and/or to complete a short questionnaire. These will take place at 6, 12, 26 and 52 weeks. To assess any longer-term effects, such as arthritis, we will ask patients to attend an additional follow-up appointment at 5 years. Some patients will also be asked whether they would like to take part in an interview to explore and improve understanding of patients’ attitudes towards and experiences of the treatments that are being compared in this study. This will also help us to learn about patients’ experiences of taking part in a research study. What are the possible benefits and risks of participating? While the selection of treatment (surgery or plaster cast) is left to chance, patients will receive the same standard of care as they would normally. The surgeon and other people providing care are experienced in the treatments provided. There are no new treatments being tested in this study. There are risks associated with having any operation, such as infection, bleeding and very rare damage to the nerves, however, it is possible that this may restore hand function earlier and avoid the need to have the wrist held in a plaster cast for 6 to 10 weeks. There are also possible long term effects if the fracture does not join. If left untreated, this often leads to arthritis within 5 years. One in ten fractures treated in a plaster cast do not heal and can lead to delayed surgery. The plaster cast treatment, however, can prevent the need for the majority of patients to have an operation and the extra risks involved. Because we do not know what treatment is best, patients may not benefit from taking part. If, however, enough people take part in this study, the information we get should help ensure that people with these fractures have the best treatment in the future. Where is the study from? We will recruit patients from hospitals across the UK. When is the study starting and how long is it expected to run for? The study will start in April 2013 and end in April 2022. Who is funding the study? The NIHR Health Technology Assessment Programme (HTA), UK. Who is the main contact? Professor Joe Dias jd96@leicester.ac.uk |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial and economic evaluation |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Musculoskeletal trauma of the hand and wrist |
| Participants - inclusion criteria |
1. Adults (male and female), aged 16 years old or above
2. Presenting to the trauma centre within 2 weeks of their injury 3. Radiologically confirmed bicortical fracture of the scaphoid waist |
| Participants - exclusion criteria |
1. Fractures greater than 2mm displaced
2. Fractures in the proximal pole of the scaphoid (proximal 20%) 3. Trans-scaphoid perilunate dislocation 4. Multiple injuries in the same limb 5. Previous injury or disease in the same wrist 6. Patients with cognitive impairment 7. Patients not resident in the trauma centre catchment area 8. Any other reason to exclude the patient (please give reasons) |
| Anticipated start date | 01/04/2013 |
| Anticipated end date | 31/03/2022 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 438 |
| Interventions |
Participants will be randomised to one of two basic treatment interventions:
1. Surgery using a headless screw 2. Plaster cast immobilisation |
| Primary outcome measure(s) | The Patient Rated Wrist Evaluation (PRWE) (15 item condition-specific questionnaire providing a total score based on the patient's subjective assessment of wrist pain and disability in activities of daily living), assessed at 52 weeks |
| Secondary outcome measure(s) |
1. The PRWE at 6, 12 and 26 weeks and at 5 years
2. The 12-item short form health survey (SF-12) and Euroqol (EQ-5D) for general health status data (at 6, 12, 26, 52 weeks and 5 years) 3. Bone union, determined by CT scan and radiographs at 52 weeks and 5 years 4. Range of wrist movement (measured using goniometer at 6, 12, 52 weeks and 5 years). 5. Grip strength (measured using a calibrated Jamar dynamometer at 6, 12, 52 weeks and 5 years) 6. Complications, including surgical complications (e.g. wound infection) at 6, 12, 52 weeks 7. Early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism. 8. Subsequent referral for operation or substantive treatment. Duration of follow-up: 5 years 9. Data for economic evaluation: NHS and societal costs |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) (11/36/37) |
| Trial website | |
| Publications | |
| Contact name | Prof Joe Dias |
| Address |
Clinical Sciences Unit, Off Ward 11
Leicester General Hospital Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| Tel | +44 (0)116 258 4702 |
| jd96@leicester.ac.uk | |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Address |
Leicester General Hospital
Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| Sponsor website: | http://www.leicestershospitals.nhs.uk/ |
| Date applied | 07/02/2013 |
| Last edited | 13/02/2013 |
| Date ISRCTN assigned | 13/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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