Endoscopic versus Open Cubital Tunnel Release: An Open Randomized Clinical Trial

Cubital tunnel syndrome is the second most common entrapment neuropathy of the
upper extremity after carpal tunnel syndrome. The complaints can consist of
pain, tingling and reduced or no feeling in the ring finger and little finger,
loss of strength, reduced fine motor skills and contractures of the hand. If
conservative treatment fails to improve symptoms, surgery is indicated.
Surgical cubital tunnel decompression is performed 7500 per year in the
Netherlands. For surgical decompression, two methods are being used in common
practice: an open release or an endoscopic release. The endoscopic approach was
introduced in the early 1990s because it is less invasive; meaning a smaller
skin incision and less soft tissue damage. Potential benefits include faster
recovery and less risk of damage of the ulnar nerve and its side branches due
to better vision during surgery. Another possible benefit is a better treatment
experience by the patients, partly because of image reproduction of the
operation.
There is ongoing debate as to what constitutes the superior surgical approach.
Currently, the choice for one of the methods is based on surgeon*s preference
based on the surgeon*s degree of familiarity and confidence with a particular
technique which is mostly the open technique on the assumption that this is
easier, faster and cheaper.
Few meta-analyses are performed in which the two surgical techniques
are compared. These analyses are based on low- to moderate-quality
retrospective observational studies and only three prospective studies. All
three prospective studies found no differences between the endoscopic and open
technique considering clinical results and patient satisfaction. However, these
findings should be interpreted with caution as only two studies are randomized.
Also, the follow-up period differed and the number of included patients is
relatively small and the authors concluded that larger randomized controlled
trials (RCTs) are needed to confirm their results.
So far, only outcome measures such as symptom reduction, pain and
patient satisfaction have been used and no validated patient reported outcome
and experience measures (PROMs / PREMs), despite the fact that the value of
these outcome measures in improving quality of care has already been proven.
These outcomes are particularly important since objective measures might not
adequately reflect success of a surgical procedure. Modern medicine is shifting
towards feedback of patients and having a better understanding of patients*
experience. Therefore, including these measurements in trials is an important
addition to the current literature.
The American Society for Surgery of the Hand (2018) states that research data
on the optimal surgical treatment for cubital tunnel syndrome remains
inconclusive. In addition, the Dutch guideline is based on the limited
scientific literature of low quality. Therefore, we want to perform a
high-quality RCT with sufficient power to compare the clinical effect (PROMs)
and treatment experience (PREM) of the open and endoscopic decompression.

To make an evidence-based recommendation on which method has the best efficacy
(PROM), patient treatment experience (PREM) and safety profile (complications).

This is an open randomized controlled trial. The follow-up will be 18 months
from baseline. All eligible patients will be asked to participate in this study
and will receive additional information. If informed consent is obtained,
patients are randomized to receive cubital tunnel release using the (1) open or
(2) endoscopic approach. The surgeon and patients are not blinded for treatment
allocation.

An open or endoscopic cubital tunnel release. Both the open and endoscopic
cubital tunnel release are common clinical practice in patients having cubital
tunnel syndrome. In the Jeroen Bosch Ziekenhuis, both types of surgery are
performed on a regular basis.

There is no other difference in benefit nor risk for the individual patient
compared to the treatment of cubital tunnel syndrome in common practice since
both treatment arms are currently standard practice. Published data will be
fully anonymised.

After this study, we hope to conclude which type of surgery is most effective
in the treatment of cubital tunnel syndrome. A long-term benefit will therefore
be enhancement of the quality of care and cost-effective for patient and
community. However, this is no direct benefit for the participant itself.