Novel Elbow Splint Commences Clinical Trials in Patients with Ulnar Neuropathies | News » Health Enterprise East

22 November 2016

Health Enterprise East (HEE), has announced that it is to commence clinical trials at Cambridge University Hospitals NHS Foundation Trust, a world renowned centre of healthcare innovation, of the Cambridge Ulnar Splint for treatment of patients suffering neuropathies at the elbow. 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 CUH NHS Foundation Trust. 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.

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

​Figure1. Cambridge Ulnar Splint in deployed position to prevent bending/flexion at the elbow.

Figure 2. Cambridge Ulnar Splint in relaxed position when support not required, allowing elbow flexion.

Dr Andy Michell added: “This is a significant milestone in the development of the Cambridge Ulnar Splint and we look forward to the trial results. This is the first splint specifically design 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.”