FOREST is short for Fix Or Replace Enhancing distal humeruS fracTure outcomes. It is a phase III, multicentre, parallel-group, superiority RCT to compare upper limb specific function between elbow arthroplasty and fixation of the fracture using plates and screws in patients presenting with a fracture of the distal humerus. Our target population is adults 60 years of age and over with an intra-articular fracture of the distal humerus.

A broken elbow is a common injury, particularly amongst older people. If the bone is badly broken, recovery is difficult and people often suffer with pain and stiffness even after the break has healed. It is important that we offer people the best chance of making a full recovery, which is why we are doing this trial.
The FOREST trial compares two different operations to treat an elbow fracture:

• Elbow replacement. A joint made of metal and plastic is used as a replacement. The two metal parts are inserted into the bone cavity of the upper and lower arm and then secured with bone cement. The two metal parts may be connected like a hinge or be separate. Sometimes, only part of the joint needs to be replaced. 
• Elbow repair. The bones will be repositioned to restore the normal position of the bones and joint. Once in place, plates and screws will be attached to hold the bones together. The plates and screws are designed to stay in place for life and will hold the broken bone together while it heals.

They both help to reduce pain and maintain or improve movement. However, doctors don’t know yet which one works best. The aim of the trial is to find this out.

You have been invited to take part in this trial as you are aged 60 years or over and have fractured your elbow and you need surgery.

We are looking for 320 patients to take part in this research.

It is up to you whether or not you take part in the trial. Even if you agree now, you are free to withdraw at a later date if you wish. We will talk to you about the trial and answer any questions you may have. If you agree to take part, we will ask you to sign a consent form. 

Consent
If you decide to take part in the trial you will be asked to sign a consent form. With your permission, we will inform your GP about your participation in this trial. You can indicate on the consent form if you are happy to be contacted in the future about taking part in further research studies. Whilst signing the consent form officially enrols you into the trial, it is important to remember that you are free to withdraw at any time, without giving a reason. This will not affect the standard of care you receive.

Randomisation
Taking part in a research trial means that neither you, the doctors, or the research team can choose which surgery you will get. Your treatment will be allocated using a scientific process called randomisation. This means you will have an equal chance of having an elbow replacement or an elbow repair. Randomisation is used as it creates groups of patients that are similar except for the treatment received. This will enable a fair comparison of the different treatments so we can assess at the end of the trial which one is best for future patients.

Your surgery
Your surgery will be performed by a surgeon who is trained and experienced in the surgery you will be having. In some cases, this might mean travelling to a specialist hospital, different to the one where you attended the fracture clinic. This is commonplace in these injuries, as the surgery is only performed by highly specialised surgeons.
During your surgery you will have the procedure assigned to you at randomisation. However, if for whatever reason, the surgeon decides during the procedure that it is in your best interests to have a different procedure they may change the operation performed. It is highly unlikely that this will happen as your x-rays will have guided the decision before your operation that you were suitable for either procedure, but there is always a possibility.
After your surgery, you will receive the same check-ups and physiotherapy as any patient who has elbow surgery in your hospital. There is no difference for patients that do not take part in the trial.

Your data
We would like to follow you up for 1 year after your treatment to find out how you are doing and how your elbow is. We will do this by asking you to complete some questionnaires up to 5 occasions. This will be before your surgery, then repeated at 6 weeks, 4 months, 12 months.
You may also be informed at 12 months about the possibility of completing a questionnaire about your elbow recovery when the trial has reached its 49th month (approximately 2.5 years).
You will be asked to complete these questionnaires either when you attend for your routine clinic follow-up appointment (arranged by the hospital) or the questionnaires will be sent to you by text, email or post, according to your preference. Reminders to complete questionnaires may also be sent and may include a telephone call from a member of the site research team. The questionnaires should take no longer than 20 minutes, each time, for you to complete.

We will not cover your travel or parking costs for any visits during the trial. If you need to go to a specialist centre, hospital transport may be available. Please talk to your local care team if you need help arranging this (contact details are at the end of this information sheet).

You will not be paid for taking part in this study. As a token of appreciation for your time, once you have completed the 12-month questionnaires, you will receive a £30 gift voucher for taking part in the trial.

Taking part in the trial may not directly benefit you, but the information we collect from this trial may help us to treat people who have a fracture to their elbow in the future.

There is no increased risk to you by participating in the trial. The NHS has treated patients with these operations ​​for many years. You will face the same risks of surgery and receive the same care as patients who are having these surgeries without taking part in the trial. 

If you have concerns or questions about any aspect of this trial, you should ask to speak to the local researchers. Their contact details are at the end of the Patient information sheet they handed out to you.
If any questions remain you can contact the trial coordinating centre:
Email: forest@nottingham.ac.uk

If you remain unhappy and wish to complain formally, you can do this through the National Health Service (NHS) Complaints Procedure via your local Patient Advisory and Liaison Service (PALS).
In the unlikely event that something does go wrong and you are harmed during the trial, there are no special compensation arrangements. If you are harmed and this is due to someone’s negligence, then you have grounds for a legal action for compensation but you may have to pay your legal costs. The normal NHS complaints mechanism will still be available to you.

You are free to withdraw at any time, without giving any reason, and without your legal rights being affected. If you would like to withdraw, contact your local researchers and they can organise this for you. If you withdraw the information collected will not be erased and this information may still be used in the trial analysis.

If you are no longer able to make decisions for yourself, you will be withdrawn from the trial. The information collected will not be erased and this information will still be used in the project analysis.

Nottingham University Hospitals NHS Trust is the sponsor for this trial and is the organisation responsible for making sure that the trial is carried out correctly. Researchers at the Nottingham Clinical Trials Unit (part of the University of Nottingham) and the sponsor will need to use information from you and your medical records, for this research project. This information will include your initials, name and contact details including email and phone number so we can send you questionnaires and reminders. The researchers will use this information to do the research or to check your records to make sure that the research is being done properly. The researchers at Nottingham Clinical Trials Unit will also have access to a copy of your signed Informed Consent Form for review and to confirm that the study is being conducted in accordance with appropriate quality standards.
Your name and telephone number will be shared with Esendex, our text messaging provider and will be used to send you text message reminders about the trial and trial questionnaires, if required, whilst you are participating in the trial. Esendex will keep the information shared with them for two years or until the end of the trial (whichever occurs first) before it is destroyed.
People who do not need to know who you are will not be able to see your name or contact details, your data will have a code number instead. All information about you will be kept safe and secure.
Once the trial has finished, some of the data will be kept so the results can be checked and you can be told what happened in the trial (unless you tell us you do not want to know). Reports will be written in a way so that no-one can work out that you took part in the trial.
In line with the regulations, at the end of the trial your data will be securely archived for a minimum of 5 years. Arrangements for confidential destruction will then be made.

You can stop being part of the trial at any time, without giving a reason, but we will keep information about you that we already have.
If you choose to stop taking part in the trial, we would like to continue collecting information about your health from your hospital. If you do not want this to happen, tell us and we will stop.
We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
If you give us your permission, we may keep your contact details so we can get in touch if there is any relevant future research to do with your condition that you may be interested in taking part in. You will also have the option to take part in future research using your data saved from this trial. If you do not wish for your contact details to be kept for a copy of the trial results to be sent to you or to be contacted about future research, these will be disposed of securely at the end of the trial.

You can find out more about how we use your information:
• at www.hra.nhs.uk/information-about-patients/ and www.hra.nhs.uk/patientdataandresearch
• at https://www.nuh.nhs.uk/data-requests-your-privacy
• at http://www.nctu.ac.uk/data-protection/data-protection.aspx
• by asking one of the local care team • by sending an email to forest@nottingham.ac.uk
• by writing to FOREST Trial, NCTU, Applied Health Research, University of Nottingham NG7 2RD

Sometimes we get new information about the treatments being used to treat your condition during the trial. If this happens your research doctor will tell you about this new information and discuss whether you should continue in the trial. If you decide not to carry on, your research doctor will make arrangements for your care to continue as normal. If you decide to continue in the trial, they may ask you to sign a new Informed Consent Form.

When the trial ends, your healthcare will continue as normal. If you withdraw from the trial, we will need to keep and use the data collected up to your withdrawal. At the end of the trial the results will be published in scientific medical journals and presented at conferences. You will not be identified in any publication. We will send you a newsletter with a summary of the trial findings, unless you ask us not to. The results from the trial will also be made available on the trial website.