REACTS

• Research type

  Research Study

• Full title

  A Randomised Controlled Trial of End-to-Side Anterior Interosseous Nerve Transfer Augmentation of Ulnar Nerve Function in Moderate and Severe Cubital Tunnel Syndrome

• IRAS ID

  311475

• Contact name

  Dominic Power

• Contact email

  Dominic.Power@uhb.nhs.uk

• Sponsor organisation

  University Hospitals Birmingham NHS Foundation Trust

• ISRCTN Number

  ISRCTN18379703

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  This feasibility study will help to inform the design and sample size for a subsequent larger multi center RCT to understand whether the addition of a nerve transfer to patients having surgery for cubital tunnel syndrome helps to improve muscle strength in the hand.

  Design and methods:
  Patients with cubital tunnel syndrome and hand muscle weakness will be provided with information about the study and asked if they would like to take part. If they agree they will be randomly assigned to have a cubital tunnel release operation or a cubital tunnel release operation plus an additional nerve transfer. Both groups of patients will have a number of measurements taken to assess their function before surgery and 3, 6, and 12 months after surgery. These assessments will include strength of the hand, feeling in the hand, and questionnaires about how well the hand works. The study is designed to better understand whether a nerve transfer improves hand function. The results will be used to improve treatment for patients with cubital tunnel syndrome and guide future research into this condition.

  Patient and public involvement
  A patient and public involvement and engagement (PPIE) group has been established that includes members that have received treatment for cubital tunnel syndrome. The group has been involved in the development of this research question and the trial design. They have reviewed and approved the protocol, all patient-facing documents that will be used in this study, will assist in the interpretation of results and have provided guidance on how these results should be shared with the public.

  Dissemination
  The results of this study will be published in a peer reviewed medical journal. The findings will be presented at scientific congresses. Infographics detailing the results will be prepared and released to the press and on professional social media platforms.
  

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  24/WM/0013

• Date of REC Opinion

  20 Mar 2024

• REC opinion

  Further Information Favourable Opinion