Trial Status: Open to Recruitment
Repair of digital nerve injury
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 intheir 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
Aims & Objectives
The aim is to conduct arandomised trial comparing exploration and washout with microsurgical repair with 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.
Digital nerves are small nerves which pass along the side of each finger and provide important sensation to the fingertips. These nerves can be accidentally cut when handling sharp objects like broken glass or a knife. We want to find out whether surgical repair of the nerve (suturing the ends together) is beneficial by seeing if patients do just as well without complex surgical repair. Despite the rationale for sewing the ends of cut nerves together it remains unclear whether repair is the best treatment, or even needed. One suggestion is that surgical repair, which involves placing sutures in thetissue around the nerve, is effective and gives good results. There is also evidence that many patients, who do not have surgical repair, are able to return to work without problems. Furthermore, even after surgical repair, the feeling in the injured finger often does not return to pre-injury levels which may create difficulties with everyday tasks. The implication is that the operation may be unnecessary and that just cleaning the cut, a much simpler procedure, may be satisfactory for patients. The research done so far shows conflicting results and is of varying quality. Many studies have included too few patients, did not directly compare surgical repair with no repair or have not asked the patient how they feel about the outcome of their treatment. 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.
The best way to assess whether surgical repair of digital nerves is appropriate is to compare the surgical repair procedure with a surgical procedure without a repair (a simple washout of the wound), in a research study. Patients are prescribed one of these two treatment options by random allocation. Assessment of benefit will be made using patient questionnaires measuring fingertip sensation, quality of life and return to work. Patients in both groups will be assessed after each procedure at 6 weeks, 3, 6 and 12 months. Given the differences in costs of the surgical procedures and the potential need for further treatment, it will also be important to assess whether surgical repair is a good use of NHS resources. 478 patients with digital nerve injuries will be included in the study. Patients with this injury are part of the study team and have been involved in preparation of this application. Additionally, we have consulted a group of patients with digital nerve injuries about our plans for a study and what is the most relevant and acceptable way to measure outcome. We will continue to involve patients in designing patient-facing information and as members of the trial steering group. Our application is also 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. The results of our study will be published via the HTA website and in medical journals. The study team will present the results at association conferences. Our study website will present the results and a summary given to participants. To reach the wider patients and public we will make our results available through public websites like NHS Choices.