Scaphoid Waist Internal Fixation for Fractures Trial: A trial evaluating cast versus surgical fixation for fractures of the scaphoid waist in adults

Plain English 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?
April 2013 to April 2022

Who is funding the study?
The NIHR Health Technology Assessment Programme (HTA), UK

Who is the main contact?
Prof. Joe Dias
jd96@leicester.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

Website	http://www.leicestershospitals.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

19/08/2021: The following changes were made to the trial record:
1. The participant level data was changed from 'To be made available at a later date' to 'Available on request'
2. Publication references added.
12/08/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2022 to 31/07/2016.
2. The intention to publish date was changed from 01/10/2022 to 31/12/2019.
06/06/2016: Publication reference added.