UNDER Study: Ulnar Nerve Decompression Endoscopic Randomisation Study
Research type
Research Study
Full title
A prospective randomised controlled trial comparing endoscopic decompression of the ulnar nerve with open decompression in the surgical management of cubital tunnel syndrome
IRAS ID
324952
Contact name
Dominic Power
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Clinicaltrials.gov Identifier
OCTRU379, Oxford Clinical Trials Research Unit (CTU) ref
Duration of Study in the UK
4 years, 0 months, 30 days
Research summary
Cubital tunnel syndrome is when a nerve is squashed at the elbow causing tingling and numbness in the hand, clumsiness of fine finger movements and loss of grip strength. Persisting symptoms can be treated with decompression surgery to release tight structures lying over the nerve.
There are two ways of performing decompression, one with open surgery where a cut is made in the skin along the course of the nerve, the other by keyhole surgery (endoscopic), with a small cut and using a camera to help see the nerve.
There are potential advantages and disadvantages of both techniques. After release, if the nerve moves excessively as the elbow bends the surgeon may need to correct the movement. This is easier with an open technique, but the extra scar tissue from open surgery may cause symptoms to return. The keyhole surgery uses a smaller incision which may allow patients to recovery more quickly but is not currently performed regularly by UK surgeons.
The study will involve two phases. During the first phase surgeons will be trained to do the endoscopic surgery and information will be collected to help understand how quickly they learn the new skill and how well patients recover from surgery. The second phase involves conducting a study to compare the open and endoscopic operations using a randomised controlled trial. Patients agreeing to the study will be assigned at random to one of the two techniques (open or endoscopic). Information about their condition and recovery will be collected before and after surgery for a period of 6 months; 334 patients will be included from hospitals across the UK.
To help design the best study we conducted a national survey of specialist surgeons who treat this condition and consulted researchers, statisticians, health economists and patients treated for cubital tunnel syndrome. A group of patients who have had treatment for cubital tunnel have agreed to be part of the Patient and Public Advisory Group (PPAG). They have helped design the study to make it easy for patients to take part with little burden. They have reviewed the selected outcomes measures and agreed that the PRUNE (Patient Reported Ulnar Nerve Evaluation) score is simple to complete and relevant to their symptoms. The patient group will continue to support all stages of the study. We have a patient representative as part of the study team.
The results of this study will provide evidence to guide future decision making for patients and clinicians in the treatment of cubital tunnel syndrome. We will publicise the study results widely to ensure they will be available to patients, the public, clinicians, healthcare managers and commissioners of treatment in the NHS.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
24/WM/0002
Date of REC Opinion
15 Jan 2024
REC opinion
Favourable Opinion