Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT04647058
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years of age or older
* Severe cubital tunnel syndrome is defined in this study as McGowan classification stage IIB or III disease (sensory deficits, motor deficits, and the presence of intrinsic atrophy)
* Indicated for surgical treatment of severe cubital tunnel syndrome at one of the two participating institutions
* Preoperative nerve conduction study and electromyography documenting ulnar neuropathy at the elbow with present fibrillations and positive sharp waves in the FDI or ADM within one year of surgery
Exclusion Criteria:
* Ulnar nerve transections
* Traumatic brachial plexus injuries
* Brachial plexus neuritis (e.g. Parsonage-Turner)
* Cervical radiculopathy
* Primary motor neuropathy (e.g. Charcot-Marie-Tooth)
* Prior cubital tunnel surgery
* Oncologic etiologies of ulnar nerve compression
* Patients who are not capable of decision-making or are unable to understand the study procedures
* Non-English speaking patients are excluded since our secondary outcome variables may not have been translated and validated in other language(s).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04647058
Study Brief:
Protocol Section:
NCT04647058