Award Title: 18/37 - Repair of digital nerve injury
Funder: Department of Health and Social Care

Abstract: Digital nerves are small nerves that pass along the side of each finger and provide sensation to the fingertips. These nerves can be accidentally cut when handling sharp objects like a knife or broken glass. The NEON study aims to find out whether repairing the nerve surgically (sewing the ends of the cut nerve) is beneficial or even needed. Thoroughly cleaning the cut before closing the skin is a much simpler procedure, and may be satisfactory for patients._x000D_
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There is some evidence that both treatments give good results. There is also some evidence that patients may not fully recover the feeling in their injured finger, even after the nerve has been surgically repaired. Research so far has been conflicting and is of varying quality. For example, some studies do not directly compare treatments, or do not ask patients about their views of recovery._x000D_
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The best way to find out if surgically repairing digital nerves is appropriate is to conduct a research study. The National Institute for Health Research (NIHR) have commissioned research to address this clinical question. A recent patient/public consultation fully supports the need for more research comparing surgical and non-surgical treatments in hand conditions (http://www.bssh.ac.uk/patients/bssh_james_lind_alliance_partnership.aspx). _x000D_
NEON will compare surgical procedures for digital nerve injury, with and without a nerve repair. 478 patients will have one of these two treatment options by random allocation. Patient questionnaires measuring fingertip sensation and quality of life will assess the benefit of each treatment. Patient recovery in both groups will be checked after the procedure at 6 weeks, 3, 6 and 12 months. Given the cost difference of the procedures and the potential need for further treatment, it will also be important to look into whether surgical repair is a good use of NHS resources. _x000D_
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The study is supported by the specialist surgical societies in the UK such as the British Association of Plastic Surgery, the British Society for Surgery of the Hand and the Reconstructive Surgery Trials Network. Patient representatives who have had this injury are part of the study team and are members of the trial steering group._x000D_
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The results of our study will be published via the funder’s website and in medical journals. The study team will present the results at association conferences. The study website will present the results and a summary given to participants. To reach the patients and public more widely we will make our results available through public websites like NHS Choices.

Lay Abstract: Research Question: Does microsurgical nerve repair offer clinical benefit and cost effectiveness (in terms of patient reported hand function, sensory recovery and adverse events) over exploration and washout without microsurgical repair in adult patients with recent traumatic digital nerve injury?_x000D_
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Background: Digital nerve injury is common, often sustained through sharp lacerations. Treatment involves specialist referral and direct end to end microsurgical repair of the cut nerve ends in an operating room by a hand surgeon. There is conflicting evidence as to the efficacy and necessity of nerve repair and some evidence that patients have good outcomes even when the nerve is not repaired. The perceived advantage of performing repair is that accurate coaptation of the nerve endings is more likely to result in a better outcome for patients and possibly fewer complications such as neuroma formation. Despite the specialist resources required for this surgical repair procedure there is limited evidence, with regards to patient reported outcome measures or functional improvement, that surgical repair offers significant benefit to patients. A systematic review conducted in 2018 showed most studies were of poor quality and did not consider patient reported outcomes in their conclusions. Only 24% of patients regained what could be considered “normal” sensation. Pooled data in the review indicated there was no evidence that adverse outcome was higher if a nerve was left unrepaired (neuroma rate 4.6% repaired versus 5.0% unrepaired). Where the nerve was not repaired the majority regained protective sensibility and all patients declined further surgery to improve their sensibility suggesting they were satisfied with their outcome._x000D_
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Aims & Objectives: The aim is to conduct a randomised trial comparing exploration and washout with microsurgical repair to exploration and washout alone for patients with digital nerve injuries. The primary objective is to ascertain the patient reported clinical efficacy (and effectiveness) of microsurgical repair for patients with digital nerve injuries using the patient-reported Impact of Hand Nerve Disorders (I-HaND) scale assessed at 12 months. Secondary objectives include:  Assessing neurosensory and function recovery in both patient groups; comparing complications of surgery and clinically problematic neuroma rates; and providing a basic comparison of costs, QALYs and cost effectiveness between the repair and no repair groups._x000D_
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Methods: A multicentre, patient and assessor blinded randomised trial, run over 4 years, with patient questionnaires and clinical follow up over 12 months, and longer-term follow up using routine data._x000D_
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Impact & Dissemination: Results will be disseminated via a published funder report, academic journal, and to patients and clinicians through the surgeon societies and patient groups. Administering specific surgical treatment of unknown efficacy or value is problematic for both individual patient well-being and the health service. If surgical repair is not necessary, or less effective, than other forms of treatment then the practice should be changed. There are resource implications for the healthcare system and there may be a risk of complications or unsatisfactory outcome for individual patients if inappropriate practice is continued.

Research Activity Codes: 6.4 SURGERY
Health Categories: INJURIES AND ACCIDENTS