PROTECT Neuro is a multicentre international prospective cohort study evaluating the POLYGANICS Neurocap in the treatment of symptomatic end neuromata.
The device is made from a bioresorbable polymer that shields the nerve from the surrounding tissues following neuroma resection and early results from the STOP Neuroma pilot study have demonstrated excellent reduction in neuropathic pain. The trial will close to recruitment in July 2018 with 69 patients having been enrolled in the study.
There are 21 nerve injury centres enrolling patients across the USA and Europe. The peripheral nerve service in Birmingham is the leading recruitment centre with 20 patients treated to date. Birmingham is the only centre involved in the UK.
The NIHR SRMRC supports this trial both with our nurses conducting all the screening and consenting for the trial locally and the clinical trial management team providing administrative support.
A neuroma may develop following trauma or amputation and many result in disabling neuropathic pain necessitating lifelong opioid medication. There are no standard satisfactory treatment options for a symptomatic neuroma and many patients are not offered any treatment because of concerns about exacerbating neuropathic pain. The early results are promising and the PI Dominic Power presented the 12-month preliminary clinical outcome data at the Federation of European Societies for Surgery of the Hand Conference in Copenhagen in June 2018. All enrolled patients will be followed for 24 months to evaluate intermediate-term outcomes. Favourable results will result in the Neurocap becoming a mainstream treatment option for symptomatic neuromata in the UK in the next 2 years.