What is the Study investigating?
UNDER Study is comparing Endoscopic decompression and Open decompression surgery for the treatment of Cubital Tunnel Syndrome. The study is also investigating the training of surgeons for the delivery of the Endoscopic decompression technique.
Is every surgeon at the hospital involved in UNDER Study?
Surgeons who have received training in the Endoscopic decompression will be involved in UNDER Study. This may be a single senior surgeon or a small group.Â
Will the patient or surgeon get to choose which surgical technique is used?
No. Participants involved in the Cohort phase will receive exclusively the Endoscopic decompression surgery. In the Main Study, the choice surgery will be decided using a computer programme to allocate it randomly.
Will the patient know which surgery they received?
Yes. There is no way to conceal which surgery has been used so the patient will be informed before their surgery.
Do all patients at a recruiting hospital have to join the study?
No. Entry into the study is purely voluntary. If the patient does not want to be involved, they will receive the usual method of treatment delivered at the hospital. Patients entered into UNDER Study will also be able to withdraw from the study, if they wish.
Who can take part?
- Adult patients aged 18-80 years at the time of surgeryÂ
- Clinical and neurophysiological diagnosis of cubital tunnel syndrome (CuTS) [moderate / severe CuTS with subjective or objective motor weakness] or persistent symptoms of CuTS after a 3-month period of activity modification for mild severity cases
- Patients willing to be randomised to either Endoscopic Decompression or Open Decompression surgery for CuTS (Main study only)
Patients will not be included if they meet the following:
- Patients with a previous surgery for CuTS in the same limb
- Pre-operative ulnar nerve subluxation at the elbow identified on clinical examination
- Clinical diagnosis of CuTS with normal neurophysiology studies
- Planned concomitant surgery in the same arm
- Patients unable to provide consent
- Patients unable to complete the follow up pathway including completing follow-up questionnaires
What will the study involve after surgery?
Patients in the Cohort phase will have an appointment at 6-weeks to answer some questions.
All participating patients (both Cohort and Main Study), will have an appointment at 3-months post-surgery for a clinical assessment. In addition, the patient will complete either postal or electronic questionnaires after 3 and 6 months. The patient may receive a questionnaire 2 years after surgery as well.
Will the patient's data be kept confidential?
Yes. The patient will be allocated a study number and all patient information will be stored securely.
For further details, Patient Information Sheets can be downloaded from the top right of this page
