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Clinical Trial Begins for Elbow Splint Designed to Treat Ulnar Neuropathies

By Health Enterprise East | October 31, 2016

First patients recruited at Addenbrooke's Hospital in England.

Health Enterprise East (HEE), a National Health Service (NHS) innovation hub, is beginning clinical trials at Cambridge University Hospitals NHS Foundation Trust for the Cambridge Ulnar Splint, designed to treat patients suffering elbow neuropathy.

This common condition, sometimes known as cubital tunnel syndrome, is caused by nerve entrapment that often results in numbness of the little and ring fingers, and sometimes considerable pain and disability for patients. It is particularly prevalent in jobs such as manual labour and office work where repetitive tasks with protracted periods of elbow flexion are involved.
The splint has been developed by Dr. Andy Michell, a consultant in clinical neurophysiology at Cambridge University Hospitals NHS Foundation Trust, with support from HEE and Cambridge University Hospitals. The device won a HEE Innovation Award in 2015, with the funds used to prepare for clinical evaluation through early stage prototyping and device manufacture. Results of the clinical trial are due to be announced in early 2017.

"“This is a significant milestone in the development of the Cambridge Ulnar Splint and we look forward to the trial results," Michell added. "This is the first splint specifically designed to protect the nerve at the elbow, unlike the braces and splints currently available to patients. We anticipate it being used like the carpal tunnel splints, which are popular worldwide. –The Cambridge Ulnar Splint could be purchased directly by patients, or provided in primary care. We are seeking commercial partners to help us take the splint to market."”
The Cambridge Ulnar Splint is a first-line, early intervention treatment that, once developed, will be available to patients over the counter. It provides a flexible exoskeleton to help alleviate direct pressure on the trapped nerve, and stops the nerve irritation that causes symptoms such as pain, numbness and tingling in the fingers. The device also has a simple mechanism whereby flexion of the elbow can be restricted as and when required, making it adaptable and particularly patient-friendly.
James Clulow, technology associate at HEE said, "“This is a great example of HEE working collaboratively with innovative individuals within the NHS to develop their ideas and help transition, in this instance, from an initial concept through prototype development, to a device that is ready for clinical trials. We eagerly await the trial results and look forward to seeing the splint commercially available and making a real impact with patients."”
Health Enterprise East is an NHS innovation hub committed to improving healthcare through the provision of professional business and innovation management services. The HEE team works with NHS organizations nationally and medtech companies globally to support the development of products and services that meet currently unmet healthcare needs. The United Kingdom-based company offers a range of tailored services from strategic analysis and market validation, to practical advice and insight.
Through its member services, HEE also ensures that innovations from staff across the NHS are identified, developed and commercialized for the benefit of patients, staff and society. Closely affiliated with founding member Papworth Hospital NHS Foundation Trust, HEE currently serves more than 30 NHS organizations in the East of England, East Midlands and North London. Trusts can opt to sign up as members of HEE and access a full range of skills and expertise.