Taking Part in the NEON study

What will happen if I take part?

Your injury will be washed and examined to confirm that you definitely have a nerve injury in your finger. If you do, you will be treated with one of two options:

Option A: Microsurgical nerve sutures

In this group, the surgeon will use a couple of stitches on the injured nerve.

Option B: No surgical nerve sutures

In this group, the surgeon will align the nerve in the correct position, but will not use stitches.

Any additional injuries, such as tendon injuries, will be repaired as per routine care for these injuries. The wound will be closed and will have dressings and bandages put on as required. This will all be as per routine care.

Which treatment will I have?

We don’t know. The groups are sorted at random (like tossing a coin), through a computer programme. We do this because it is the best way to fairly compare the different operations. Dividing people into groups in this way is called a “randomised controlled trial”. It is the standard and most reliable way to see how good a treatment is.

Will I know what treatment I have?

No. NEON is a “blinded” trial, so you will not know which type of surgery you have had. The nurse or therapist that performs your follow up assessments will not know which treatment group you are in. This will help us to compare the two procedures as fairly as possible.

Part of our study will also assess how well the study keeps to the “blinding” process. There will be a question about blinding in some of the questionnaires you receive.

 

What happens after my operation?

Post-intervention rehabilitation

For the purposes of this study, you will be given a rehab advice sheet. If you need hand therapy for other injuries, you will be referred for this as per routine care at your hospital.

Questionnaires

The research team in Oxford will send you 4 short questionnaires up to 12 months after your surgery. They will each take around 10-12 minutes to fill out and will ask about your health and recovery since your operation. You can choose to complete these online or by post. The research team in your hospital will have access to your answers. We may get in contact by post, email or phone to remind you to complete the questionnaires.

Clinic Visits

NEON will involve coming for 2 extra clinic visits to assess your finger.  These will be 3 and 12 months after your operation. A nurse or therapist will go through some tests to check the sensation in your finger. This will involve tapping your injured finger with different sized filaments, and asking you to identify different shapes with your injured finger. This visit will take around 30 minutes.

Routine Hospital Data

We will request routine information collected about any visits to healthcare professionals related to your finger between 12-24 months after your surgery. This is so we can find out about any further treatment you have needed for your finger or any complications you have suffered.

Focus groups

After the NEON study has been running for a few months, we would like to hear participants’ views on their experience of their injury and taking part in the trial. This way, we can make changes to the study so it better serves other patients. If you are happy to be contacted, we may send you more information about this.

 

What are the possible risks to taking part?

Taking part in the study will not change the standard of care you receive. Both procedures are already performed routinely in the NHS, and there is no expected difference in risk between them, or between treatment outside of the study. Complications with this injury include bleeding and delayed healing after your operation, and impaired or altered sensation. If you have any questions or concerns about the complications associated with this injury and surgery, please speak to your local care team.

 

What are the possible benefits of taking part?

We cannot guarantee a benefit to patients who take part in this study. The results we get from the study are likely to benefit future patients with nerve injuries like yours.

 

Do I have to take part?

No, taking part in research is always a choice. If you do not take part, your choice will not change your care. You are free to leave the study at any point without giving a reason, and this will not affect your treatment. If you wish to leave the study you can contact the central team at neon@ndorms.ox.ac.uk or 01865 223489, or your local team using the details at the end of the NEON Patient Information Sheet.